Patent Application
20240252351
This disclosure relates to systems and methods for removing a natural lens of an eye.
As the eye ages, proteins in the crystalline lens begin to break down and clump together. This clumping of proteins makes a cloudy area in the crystalline lens known as a cataract that negatively impacts vision. This condition may be addressed with cataract surgery, wherein the crystalline lens with the cataract is removed from the eye and an intraocular lens (“IOL”) is implanted in its place.
During a cataract surgery, an incision may be made through the cornea (e.g., corneal margin) and/or sclera to access inside the eye. A ultrasonic emulsification tool, which may be a phacoemulsification probe, may be inserted through the incision and apply ultrasound to the cataract, breaking the cataract into fragments to be aspirated out of the eye. Ocular components and cellular structures (e.g., ocular organelles) are delicate and can be easily damaged by the ultrasound energy. Accordingly, cataract removal solutions that avoid unintentional damage to ocular components and cellular structure are desirable.
Additionally, applying ultrasound energy to the cataract and removing by way of aspiration may take ten minutes or longer, which may be nearly eighty percent of the time to perform a cataract surgery and, as such, may be prone to safety issues, which can at least include breakage of the capsular bag, damage to zonules, iris rupture, synechia uveitis, etc. Accordingly, cataract removal solutions that shorten the time to remove cataracts and/or ease removal of cataracts are desirable. Further, cataract removal solutions that preserve the capsular bag are desirable. Additionally, cataract removal solutions that reduce damage to surrounding ocular tissue (e.g., capsular bag, zonules, iris, etc.) are desirable.
The thermal systems (e.g., thermal emulsification systems) described herein may at least address one or more of the issues identified above. The thermal systems described herein may apply heat (e.g., localized heat, ultra-localized heat) to the crystalline lens to soften, melt, liquefy, emulsify, flow, and/or ease removal (e.g., aspiration) of the crystalline lens.
The crystallin lens of the eye may emulsify (e.g., liquify) when exposed to heat. Crystallins are the predominant structural proteins in the crystalline lens, which may at least include alpha-crystallins, and betagamma-crystallins. Crystallins and/or other proteins, biopolymers, and/or other lens material may emulsify (e.g., liquify) when exposed to heat. The lens may emulsify when exposed to a temperature between 64-70 degrees Celsius (e.g., exposed to a heated element and/or a heated fluid at 64-70 degrees Celsius). The lens may begin to emulsify when exposed to 64-66 degrees Celsius for under five minutes, which can leave some fragments of the lens intact. The lens can be almost completely emulsified when exposed to 66-68 degrees Celsius for one to three minutes, which can leave some thready fragments of the lens intact that can be aspirated with a fine gauge needle (e.g., 18-22 gauge needles). The lens can be completely emulsified when exposed to 68-70 degrees Celsius for under one minute, which can then be aspirated by a fine gauge needle (e.g., 30 gauge needle). Accordingly, 64-70 degrees Celsius can be a workable range for emulsifying the lens. 66-70 degrees Celsius can be the preferred range. 68-70 degrees Celsius can be more preferred if complete emulsification of the lens is desired in a shortened duration of time (e.g., less than one minute), which may be preferred to reduce the overall quantity of energy (e.g., Joules) imparted to the eye compared to lower temperatures. For example, exposing the lens to 64-66 degrees Celsius (e.g., heated element and/or heated fluid) for five minutes can impart more total energy to the eye compared to 68-70 degrees Celsius for less than one minute. Temperatures above 70 degrees Celsius needlessly expose the eye to more energy than needed to emulsify the lens. During testing, localized phase changes to a gaseous state were observed with temperatures above 70 degrees Celsius to 80 degrees Celsius. Above 80 degrees Celsius, rapid phase change to a gaseous state was observed instead of emulsification. The phase change to the gaseous state was observed to damage (e.g., burn) surrounding structures of the eye (e.g., capsular bag, zonules, etc.), which can include compromising the integrity of the capsular bag. Accordingly, temperatures above 70 degrees Celsius should not be used. The lens may be softened at temperatures below 64 degrees Celsius, but if emulsification is desired, temperatures below 64 degrees Celsius should not be used. The application of heat may be localized (e.g., ultra localized) to avoid unintentional damage to the ocular components (e.g., capsular bag) and cellular structures, which may avoid the damage that can be incurred with the application of ultrasound. The emulsification (e.g., liquification) of the lens may enable the lens (e.g., proteins, biopolymers, other components of the lens) to cleanly separate from the capsular bag.
The thermal systems may include one or more elements (e.g., wire(s), contact(s), mesh(es), loop(s), lasso(s), basket(s), scoop(s), heating zone(s), heater(s), heater cartridge(s), electrode(s), etc.) that may be temperature controlled (e.g., regulated). For example, the temperature of the one or more elements may be raised and/or lowered. The temperature of the one or more elements may be regulated based on aspiration and/or irrigation flow to compensate for convection loses (e.g., losses due to aspiration, irrigation, etc.). Heating of the one or more elements may be achieved either directly or indirectly with various energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, etc. The one or more elements may be disposed at the distal end of the thermal system such that the one or more elements may apply heat to the crystalline lens while the remainder of the system that contacts the anatomy of a patient is insulated with no, or at least diminished, heat transfer. The one or more elements can be used to emulsify the nucleus/cortex of the lens first or the peripheral regions of the lens first. The temperature of the one or more elements may be altered based on the density of the regions lens (e.g., higher temperatures for denser regions compared to lower temperatures for less dense regions). For example, the nucleus/cortex may be denser than peripheral regions. Accordingly, the temperature of the one or more elements may be higher for the nucleus/cortex compared to the peripheral regions.
The thermal systems may utilize a heated fluid (e.g., saline solution) to emulsify (e.g., liquify) the lens of the eye. The thermal systems can include an irrigation cannula (e.g., tip) that can be introduced into the eye. The irrigation cannula can include an opening through which heated fluid can flow to the lens. The heated fluid can quickly emulsify (e.g., liquify) the lens for aspiration. The flow rates and/or pressure for irrigation and/or aspiration can be adjusted for speed and/or efficacy during and after emulsification of the lens. The opening of the irrigation cannula and/or a corresponding aspiration opening can be adjusted in size for speed and/or efficacy. The heated fluid can be used to penetrate and liquify the nucleus/cortex of the lens first or the peripheral regions of the lens first. The temperature of the heated fluid can be altered based on the density of the regions of the lens, as described herein. The heated fluid can be introduced into the capsular bag to emulsify the lens. In some variants, the emulsified lens and heated fluid can be aspirated as the heated fluid is being introduced. In some variants, the emulsified lens and heated fluid can be irrigated with a fluid at a lower temperature and aspirated subsequent to emulsification of the lens.
The thermal system may include aspiration features to aspirate the softened, melted, and/or emulsified crystalline lens from the eye. For example, the system may be incorporated with an aspiration tip (e.g., phaco tip). The distal end of the aspiration tip may have localized elements (e.g., concentric rings, wires, discrete contacts, etc.) to apply heat. The aspiration tip can be fluidically coupled to a system to supply heated fluid that can be directed to the lens. In some variants, the thermal systems may include oscillating features, reciprocating features, retractable features, sharp distal ends, vibrating features, chomp features, grounding features, aspiration features, cryo features, temperature cycling features, etc. The thermal systems described herein may be incorporated (e.g., coupled, attached, integrated, etc.) with an existing irrigation and/or aspiration device, which may include positioning one or more heating elements on the distal tip of the existing device and/or fluidically coupling to a system to supply heated fluid that can be directed to the lens. The thermal emulsification systems may be handheld and/or portable. The thermal systems may include a rechargeable battery. The thermal emulsification systems 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. The one or temperature controlled elements may include a nickel and titanium alloy (e.g., Nitinol). In some variants, heating may be applied with aspiration (e.g., to provide heat/cool cycle). In some variants, only the distal tip of the thermal system is heated while the rest is insulted.
The thermal systems can be used to remove the lens without significant damage to the capsular bag and/or zonules of the eye. For example, a small incision may be made in the capsular bag to access the lens therein. The heated element(s) and/or heated fluid may be introduced through the small incision to emulsify the lens. The emulsified lens can be aspirated out of the same small incision or another small incision. With the lens removed, an intraocular lens can be placed in the bag. In some variants, with the lens removed, a material (e.g., gel) can be injected into the capsular bag. The material can fill the capsular bag. The material can include a refractive index that is the same as or at least similar to the natural lens.
In some variants, the techniques described herein relate 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 such that a temperature of the fluid at the outlet is within a range. The outlet of the tube can be directed at a lens within a capsular bag of an eye to emulsify the lens.
In some variants, the techniques described herein relate to an irrigation device, wherein the range is 68-70 degrees Celsius.
In some variants, the techniques described herein relate to an irrigation device, further including a first fluid line through the irrigation device that bypasses the heater.
In some variants, the techniques described herein relate to an irrigation device, further including a second fluid line through the irrigation device that wraps around the heater.
In some variants, the techniques described herein relate to an irrigation device, further including a valve configured to direct the flow of fluid through the first fluid line or the second fluid line.
In some variants, the techniques described herein relate to an irrigation device, wherein the valve includes a spring that biases the valve to a configuration in which the flow of fluid is directed through the first fluid line.
In some variants, the techniques described herein relate to an irrigation device, further including a user interface configured to be manipulated to overcome the biasing force of the spring to position the valve in another configuration in which the flow of fluid is directed through the second fluid line.
In some variants, the techniques described herein relate to an irrigation device, wherein the temperature sensor is disposed within a lumen of the tube.
In some variants, the techniques described herein relate to an irrigation device. The irrigation device can include a tube including an outlet that can deliver fluid to a lens within a capsular bag of an 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 that can heat the fluid flowing through the second fluid line. The irrigation device can include a valve that can direct the fluid through the first fluid line to bypass the heater or the second fluid line for heating.
In some variants, the techniques described herein relate to an irrigation device, wherein the heater is configured to heat the fluid such that a temperature of the fluid flowing out the outlet is 68-70 degrees Celsius.
In some variants, the techniques described herein relate to an irrigation device, wherein the valve is biased to direct the fluid through the first fluid line.
In some variants, the techniques described herein relate to an irrigation device, further including a user interface that is configured to be manipulated to overcome the bias of the valve to direct the fluid through the second fluid line.
In some variants, the techniques described herein relate to an irrigation device, wherein the second fluid line is coiled around the heater.
In some variants, the techniques described herein relate to an irrigation device, further including a temperature sensor disposed at the outlet.
In some variants, the techniques described herein relate to an irrigation device, wherein the heater is configured to adjust energy output based on a temperature sensed by the temperature sensor.
In some variants, the techniques described herein relate to an irrigation device. The irrigation device can include a tube including an outlet that can deliver fluid to a lens within a capsular bag of an eye. The irrigation device can include a heater that can heat the fluid such that a temperature of the fluid at the outlet is 68-70 degrees Celsius.
In some variants, the techniques described herein relate to an irrigation device, further including a temperature sensor at the outlet, wherein the heater is configured to adjust energy output based on the temperature of the fluid at the outlet.
In some variants, the techniques described herein relate to an irrigation device, including a fluid line wrapped around the heater.
In some variants, the techniques described herein relate to a method of removing a lens within a capsular bag. The method can include positioning an outlet of an irrigation tube of an irrigation device at a nucleus of the lens within the capsular bag. The method can include positioning an inlet of an aspiration tube of an aspiration device proximate the outlet of the irrigation tube. The method can include delivering heated fluid at 68-70 degrees Celsius to the lens to emulsify the lens. The method can include aspirating the heated fluid and emulsified lens from the eye.
In some variants, the method can include heating 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.
In some variants, a thermal system for removing a crystalline lens from an eye is disclosed herein. The system can include a distal tip that can have an aspiration opening and/or a heating element. The distal tip can be inserted into the eye to position the heating element at the crystalline lens. The system can include a power source that can direct electrical energy to the heating element to cause a temperature of the heating element to rise. The heating element can heat the crystalline lens to at least a glass transition temperature of the crystalline lens such that the lens flows or softens, which can ease aspiration through the aspiration opening.
In some variants, the system can include an irrigation port that can irrigate a fluid in the eye.
In some variants, the heating element can be disposed around the aspiration opening.
In some variants, the heating element can include a ring shape.
In some variants, the heating element can include a plurality of discrete elements that can be distributed circumferentially around the aspiration opening.
In some variants, the heating element can be disposed on a distal facing surface of the distal tip.
In some variants, the heating element can be retractable.
In some variants, the heating element can oscillate.
In some variants, the heating element can vibrate.
In some variants, the heating element can include a sharp tip.
In some variants, the heating element can include a cutting edge.
In some variants, the heating element can include a wire.
In some variants, the heating element can include a wire forming a loop.
In some variants, the heating element can include a plurality of wires forming a plurality of loops.
In some variants, the heating element can include a mesh.
In some variants, the system can include a receptacle to receive the aspirated crystalline lens.
In some variants, a distal end of the tip can be angled.
In some variants, the system can include insulation to protect the eye.
In some variants, the temperature of the heating element can cycle.
In some variants, the heating element can include a nickel and titanium alloy.
In some variants, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 64-70 degrees Celsius.
In some variants, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 66-70 degrees Celsius.
In some variants, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 68-70 degrees Celsius.
In some variants, the power source can direct electrical energy to the heating element to heat the crystalline lens to 64-70 degrees Celsius.
In some variants, the power source can direct electrical energy to the heating element to heat the crystalline lens to 66-70 degrees Celsius.
In some variants, the power source can direct electrical energy to the heating element to heat the crystalline lens to 68-70 degrees Celsius.
In some variants, the heating element can soften the crystalline lens.
In some variants, the heating element can emulsify the crystalline lens.
In some variants, the system can be a portable, handheld device.
In some variants, 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 an eye to position the temperature controlled element at a crystalline lens of the eye. The temperature controlled element can heat the crystalline lens.
In some variants, the system can include an energy source that can direct energy to the temperature controlled element to raise a temperature of the temperature controlled element.
In some variants, the energy source is a battery.
In some variants, the temperature controlled element can include a heat conductive material.
In some variants, the system can include an aspiration opening that can aspirate the heated crystalline lens.
In some variants, the temperature controlled element can heat the crystalline lens to soften the crystalline lens.
In some variants, the temperature controlled element can heat the crystalline lens to emulsify the crystalline lens.
In some variants, the temperature controlled element can heat the crystalline lens to a glass transition temperature such that the lens flows.
In some variants, the temperature controlled element can heat the crystalline lens to a melting temperature.
In some variants, the temperature controlled element can reach 64-70 degrees Celsius.
In some variants, the temperature controlled element can reach 66-70 degrees Celsius.
In some variants, the temperature controlled element can reach 68-70 degrees Celsius.
In some variants, the temperature controlled element can heat the crystalline lens to 64-70 degrees Celsius.
In some variants, the temperature controlled element can heat the crystalline lens to 66-70 degrees Celsius.
In some variants, the temperature controlled element can heat the crystalline lens to 68-70 degrees Celsius.
In some variants, the system can include an irrigation port.
In some variants, the temperature controlled element can be disposed on a distal facing surface of the tip.
In some variants, the temperature controlled element can be retractable.
In some variants, the temperature controlled element can oscillate.
In some variants, the temperature controlled element can vibrate.
In some variants, the temperature controlled element can include a sharp tip.
In some variants, the temperature controlled element can include a cutting edge.
In some variants, the temperature controlled element can include a wire. The wire can be retractable.
In some variants, the temperature controlled element can include a wire forming a loop.
In some variants, the temperature controlled element can include a plurality of wires forming a plurality of loops.
In some variants, the temperature controlled element can include a mesh.
In some variants, the system can include a receptacle to receive aspirated crystalline lens.
In some variants, a distal end of the tip is angled.
In some variants, the system can include insulation to protect the eye.
In some variants, the temperature controlled element can include a nickel and titanium alloy.
In some variants, the system can be a portable, handheld device.
In some variants, a temperature controlled element connected to an energy source is disclosed herein. The energy source can direct energy to the temperature controlled element to cause a temperature of the temperature controlled element to rise. The temperature controlled element can be disposed on an aspiration device and positioned at a crystalline lens to heat the crystalline lens.
In some variants, the energy source can be a battery.
In some variants, the temperature controlled element can include a conductive material.
In some variants, the temperature controlled element can heat the crystalline lens to soften the crystalline lens.
In some variants, the temperature controlled element can heat the crystalline lens to emulsify the crystalline lens.
In some variants, the temperature controlled element can heat the crystalline lens to 64-70 degrees Celsius.
In some variants, the temperature controlled element can heat the crystalline lens to 66-70 degrees Celsius.
In some variants, the temperature controlled element can heat of the crystalline lens to 68-70 degrees Celsius.
In some variants, the temperature controlled element can reach 64-70 degrees Celsius.
In some variants, the temperature controlled element can reach 66-70 degrees Celsius.
In some variants, the temperature controlled element can reach 68-70 degrees Celsius.
In some variants, the temperature controlled element can include a wire.
In some variants, a method of removing a crystalline lens is disclosed herein. The method can include inserting a tip of a thermal system into an eye to position a temperature controlled element at a crystalline lens. The method can include applying energy to the temperature controlled element to heat the crystalline lens. The method can include aspirating the heated crystalline lens.
In some variants, applying energy to the temperature controlled element to heat the crystalline lens can include raising the temperature of the crystalline lens to 64-70 degrees Celsius.
In some variants, applying energy to the temperature controlled element to heat the crystalline lens can include raising the temperature of the crystalline lens to 66-70 degrees Celsius.
In some variants, applying energy to the temperature controlled element to heat the crystalline lens can include raising the temperature of the crystalline lens to 68-70 degrees Celsius.
In some variants, the temperature controlled element can be heated to 64-70 degrees Celsius. In some variants, the temperature controlled element can be heated to 66-70 degrees Celsius. In some variants, the temperature controlled element can be heated to 68-70 degrees Celsius.
In some variants, the energy can be electrical energy.
In some aspects, the techniques described herein relate to a method of removing a crystalline lens. The method can include flowing a fluid at 64-70 degrees Celsius to the crystalline lens of an eye to emulsify the lens. The method can include aspirating the emulsified lens from the eye.
In some aspects, the techniques described herein relate to a method, wherein the fluid is at 66-70 degrees Celsius.
In some aspects, the techniques described herein relate to a method, wherein the fluid is at 68-70 degrees Celsius.
In some aspects, the techniques described herein relate to a method, further including cutting through a capsular bag of the eye to access the lens.
In some aspects, the techniques described herein relate to a method, wherein cutting through the capsular bag of the eye includes flowing the fluid at the capsular bag to cut the capsular bag.
In some aspects, the techniques described herein relate to a method, further including introducing an irrigation cannula into the eye and introducing an aspiration cannula into the eye, wherein the irrigation cannula is configured to flow the fluid to the crystalline lens, and wherein the aspiration cannula is configured to aspirate the emulsified lens from the eye.
In some aspects, the techniques described herein relate to a method, further including positioning the irrigation cannula and aspiration cannula on opposing sides of an optical axis such that an opening of the irrigation cannula faces an opening of the aspiration cannula.
In some aspects, the techniques described herein relate to a method, wherein the irrigation cannula and the aspiration cannula are juxtaposed to each other such that axes of the irrigation cannula and aspiration cannula are parallel to each other.
In some aspects, the techniques described herein relate to a method, wherein the irrigation cannula is disposed inside of the aspiration cannula.
In some aspects, the techniques described herein relate to a method, further including advancing a member through the irrigation cannula to engage the crystalline lens.
In some aspects, the techniques described herein relate to a method, further including heating the member.
In some aspects, the techniques described herein relate to a method, wherein the member is a wire.
In some aspects, the techniques described herein relate to a method, wherein the irrigation cannula includes a closed end with one or more openings disposed through a side wall.
In some aspects, the techniques described herein relate to a method, wherein the closed end includes a curved outer periphery.
In some aspects, the techniques described herein relate to a method, wherein the closed end includes a curved inner surface.
In some aspects, the techniques described herein relate to a method, wherein the irrigation cannula includes a curved portion configured to redirect flow of the fluid in a distal direction to a proximal direction.
In some aspects, the techniques described herein relate to the method of 88, wherein the irrigation cannula includes an opening that faces in the proximal direction.
In some aspects, the techniques described herein relate to the method of any of 78-84, wherein the irrigation cannula includes a flared portion that gradually increases an internal lumen of the irrigation cannula until an opening.
In some aspects, the techniques described herein relate to the method of any of 78-84, wherein the irrigation cannula includes a cutting edge disposed on a distal end.
In some aspects, the techniques described herein relate to a method, wherein the aspiration cannula is disposed inside of the irrigation cannula.
In some aspects, the techniques described herein relate to a method, wherein the aspiration cannula includes a closed end with one or more openings disposed in a side wall.
In some aspects, the techniques described herein relate to a method, wherein the aspiration cannula includes a cutting edge.
In some aspects, the techniques described herein relate to a method, wherein the cutting edge is disposed around a distal opening of the aspiration cannula.
In some aspects, the techniques described herein relate to a method, wherein the aspiration cannula includes a flared distal end.
In some aspects, the techniques described herein relate to a thermal system for cataract surgery, the system including: a tip configured to deliver a fluid at 64-70 degrees Celsius to the crystalline lens of an eye to emulsify the lens; and an opening configured to aspirate the emulsified lens from the eye.
In some aspects, the techniques described herein relate to a system, wherein the fluid is at 66-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, wherein the fluid is at 68-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, wherein the system is a handheld device.
In some aspects, the techniques described herein relate to a system, wherein the system is retrofitted to a phaco machine.
In some aspects, the techniques described herein relate to a system, further including a fluid reservoir to hold the fluid prior to delivery.
In some aspects, the techniques described herein relate to a system, further including a heating element configured to heat the fluid.
In some aspects, the techniques described herein relate to a system, further including a temperature sensor.
In some aspects, the techniques described herein relate to a system, wherein the temperature sensor is at the tip.
In some aspects, the techniques described herein relate to a system, wherein the heating element is configured to adjust the temperature of the fluid based on a temperature detected by the temperature sensor.
In some aspects, the techniques described herein relate to a system, further including a pump.
In some aspects, the techniques described herein relate to a system, further including a valve configured to impede the delivery of the fluid.
In some aspects, the techniques described herein relate to a system, further including a waste reservoir configured to hold aspirated material.
In some aspects, the techniques described herein relate to a thermal system for cataract surgery, the system including a heating element configured to heat a fluid for delivery to a crystalline lens of an eye at 64-70 degrees Celsius to emulsify the lens.
In some aspects, the techniques described herein relate to a system, wherein the heating element is configured to heat the fluid for delivery to the crystalline lens of the eye at 66-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, wherein the heating element is configured to heat the fluid for delivery to the crystalline lens of the eye at 68-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, further including a fluid reservoir.
In some aspects, the techniques described herein relate to a system, wherein the heating element is configured to heat the fluid in the fluid reservoir.
In some aspects, the techniques described herein relate 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.
In some aspects, the techniques described herein relate to a thermal system for cataract surgery, the system including: an irrigation cannula configured to deliver a fluid at 64-70 degrees Celsius to a crystalline lens of an eye to emulsify the lens; and an aspiration cannula configured to aspirate the emulsified lens from the eye.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula is configured to deliver the fluid at 66-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula is configured to deliver the fluid at 68-70 degrees Celsius.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula and aspiration cannula are configured to be positioned on opposing sides of an optical axis such that an opening of the irrigation cannula faces an opening of the aspiration cannula.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula and the aspiration cannula are configured to be juxtaposed to each other such that axes of the irrigation cannula and aspiration cannula are parallel to each other.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula is disposed inside of the aspiration cannula.
In some aspects, the techniques described herein relate to a system, further including a member configured to be advanced through the irrigation cannula to engage the crystalline lens.
In some aspects, the techniques described herein relate to a system, wherein the member is configured to be heated.
In some aspects, the techniques described herein relate to a system, wherein the member is a wire.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula includes a closed end with one or more openings disposed through a side wall.
In some aspects, the techniques described herein relate to a system, wherein the closed end includes a curved outer periphery.
In some aspects, the techniques described herein relate to a system, wherein the closed end includes a curved inner surface.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula includes a curved portion configured to redirect flow of the fluid in a distal direction to a proximal direction.
In some aspects, the techniques described herein relate to the system of 128, wherein the irrigation cannula includes an opening that faces in the proximal direction.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula includes a flared portion that gradually increases an internal lumen of the irrigation cannula until an opening.
In some aspects, the techniques described herein relate to a system, wherein the irrigation cannula includes a cutting edge disposed on a distal end.
In some aspects, the techniques described herein relate to a system, wherein the aspiration cannula is disposed inside of the irrigation cannula.
In some aspects, the techniques described herein relate to a system, wherein the aspiration cannula includes a closed end with one or more openings disposed in a side wall.
In some aspects, the techniques described herein relate to a system, wherein the aspiration cannula includes a cutting edge.
In some aspects, the techniques described herein relate to a system, wherein the cutting edge is disposed around a distal opening of the aspiration cannula.
In some aspects, the techniques described herein relate to a system, wherein the aspiration cannula includes a flared distal end.
Neither the preceding summary nor the following detailed description purports to limit or define the scope of protection. The scope of protection is defined by the claims.
The abovementioned and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of the different disclosed embodiments can be combined to form further embodiments, which are part of this disclosure.
Although certain embodiments and examples are described below, this disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular embodiments described below.
As the eye ages, proteins (e.g., crystallins) and/or biopolymers in the crystalline lens can begin to break down and clump together. This clumping of proteins can make a cloudy area in the crystalline lens known as a cataract that negatively impacts vision.
As described herein, proteins, such as crystallins, and/or biopolymers may clump together to cloud the lens 112, resulting in a cataract that impairs vision. A cataract surgery may be performed to improve vision. To perform a cataract surgery, an incision may be cut in the cornea 102 (e.g., corneal margin) and/or sclera 142 to access an interior of the eye. For example, a diamond knife tool 116 having a diamond knife 118 may be used to cut a small incision in the cornea 102 and/or sclera 142.
As illustrated in
With the lens 112 removed, as shown in
As described herein, crystallins are the predominant structural proteins in the crystalline lens 112, which may at least include alpha-crystallins, and betagamma-crystallins. 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, which is higher than the glass transition temperature. The thermal systems (e.g., thermal emulsification systems) described herein may apply heat to raise the temperature of the lens 112 (e.g., one or more proteins, biopolymers, and/or other components of the lens 112) to the glass transition temperature, resulting in softening of the lens 112 (e.g., one or more proteins, biopolymers, and/or other components of the lens 112), and/or to the melting temperature, resulting in the melting (e.g., emulsification, liquification) of the lens 112 (e.g., one or more proteins, biopolymers, and/or other components of the lens 112). In some variants, the thermal systems described herein may apply a heat that raises 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 solution) 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), melting temperature of lens 112 (e.g., one or more proteins, biopolymers, and/or other components of the lens 112), and/or between the glass transition temperature and/or melting temperature of the lens 112. The fluid can be any that is suitable for ocular procedures (e.g., saline, balanced salt solution, 0.9% saline, pharmaceutical drops, viscoelastic, etc.). Heating the lens 112 to a glass transition temperature and/or melting temperature of the lens 112 (e.g., proteins, biopolymers, and/or other components of the lens 112) may ease removal (e.g., aspiration) of the lens 112 from the capsular bag 110. The one or more elements and/or fluid can provide localized heat (e.g., ultra-localized heat) to the lens 112, which may avoid damaging other portions of the eye 100.
The lens 112 (e.g., proteins, biopolymers, and/or other components of the lens 112) may be emulsified, which may be described as liquified, at a temperature above the glass transition temperature (e.g., melting temperature). When the lens 112 (e.g., proteins, biopolymers, and/or other components) has been emulsified, the lens 112 may be removed more efficiently from the eye (e.g., from the capsular bag). For example, the lens 112 can be removed with emulsification and aspiration much quicker compared to previous methods, which can include emulsification and aspiration of the lens within seconds, less than one minute, or less than two minutes. Additionally, the liquified lens can be aspirated with less invasive techniques (e.g., a fine gauge needle, which can at least include the following gauges: 16, 18, 19, 20, 21, 22, 23, 25, 26, 27, 29, 30, and others) compared to prior techniques. The lens 112 can be emulsified from exposure to a heated element (e.g., wire, tip, etc.). The lens 112 can be emulsified from exposure to a heated fluid (e.g., saline solution).
Through experimentation, the different effects on the lens from exposure to a heat source at different temperature ranges has been discovered. For example,
When a lens 112 was exposed to a fluid at 64-66 degrees Celsius for less than five minutes, the lens 112 began to emulsify. Additional mechanical support (e.g., mechanical agitation with one or more surgical tools) was employed to break up remaining fragments 113 of the lens 112.
When a lens 112 was exposed to a fluid at 66-68 degrees Celsius for one to three minutes, the lens almost entirely emulsified with some loose thready fragments 113 still present, which can be aspirated with a fine gauge needle (e.g., 18-22 gauge needles). Some additional minor mechanical support (e.g., mechanical agitation with one or more surgical tools) was employed to assist in breaking up the fragments of the lens.
When a lens 112 was exposed to a fluid at 68-70 Celsius for less than one minute, the lens was emulsified (e.g., entirely emulsified), which can be aspirated with a fine gauge needle (e.g., 30 gauge) needle. No mechanical support was employed to assist in breaking up the lens.
Temperatures above 70 degrees Celsius needlessly expose the eye to more energy than needed to emulsify the lens. During testing, localized phase changes to a gaseous state were observed when exposing the lens to a fluid at temperatures above 70 degrees Celsius to 80 degrees Celsius. Above 80 degrees Celsius, rapid phase change to a gaseous state was observed instead of emulsification. The phase change to the gaseous state was observed to damage (e.g., burn) surrounding structures of the eye (e.g., capsular bag, zonules, etc.).
Identifying the impact of different temperature ranges on the lens was a critical discovery for successful implementation of the systems and methods described herein. As detailed herein, the lens 112 entirely emulsifies when exposed for less than one minute or two minutes to a fluid heated to 68-70 degrees Celsius. Accordingly, flowing a fluid above 70 degrees Celsius into the eye can completely emulsify the lens but needlessly exposes the eye to more energy than required to efficiently emulsify the lens. As detailed above, phase changes to a gaseous state were observed above 70 degrees Celsius, and the phase changes to the gaseous state were observed to damage (e.g., burn) surrounding structures of the eye (e.g., capsular bag, zonules, etc.). As such, the fluid introduced into the eye should not exceed 70 degrees Celsius. As detailed herein, the lens almost entirely emulsifies when exposed to a fluid at 66-68 degrees Celsius but some fragments (e.g., loose thready fragments) of lens remain intact that are small enough to be aspirated through a fine gauge needle. Accordingly, introducing a fluid at 66-70 degrees Celsius is the newly discovered preferred range for emulsifying the lens of the eye. That said, if complete emulsification of the lens is desired in a shortened duration of time (e.g., less than one minute, less than two minutes), then introducing a fluid at 68-70 degrees Celsius is preferred. Nevertheless, introducing a fluid at 64-66 degrees Celsius is also effective because the lens starts to emulsify at that temperature range, but at that temperature range, an aspiration device with a larger opening is needed to aspirate the larger fragments compared to the aspiration device used when using a fluid at 66-70 degrees Celsius or even 68-70 degrees Celsius. However, the 66-70 degrees Celsius and/or 68-70 degrees Celsius temperature ranges may be preferred to reduce the total quantity of energy (e.g., Joules) imparted to the eye compared to lower temperature ranges such as 64-66 degrees Celsius. For example, exposing the lens to fluid at 64-66 degrees Celsius (e.g., heated element and/or heated fluid) for five minutes can impart more total energy to the eye compared to 68-70 degrees Celsius for less than one minute, and it can be desirable to expose the eye to less total energy. Utilizing a fluid at less than 64 degrees Celsius resulted no significant observable emulsification of the lens 112. Accordingly, introducing a fluid at 64-70 degrees is the newly discovered workable range for emulsification of the lens. However, a temperature below 64 degrees Celsius can be employed if softening of the lens is desired as opposed to liquification.
The systems and methods described herein can employ different temperatures when emulsifying different portions of the lens. For example, the nucleus/cortex of the lens is denser than the peripheral portions of the lens. Accordingly, a higher temperature (e.g., closer to or at 70 degrees Celsius) may be employed when liquifying the nucleus/cortex compared to the peripheral portions of the lens. In some variants, the systems described herein can automatically adjust the temperature as the heating element and/or irrigation cannula (e.g., tip) is navigated around the lens 112 to compensate for changing densities. In some variants, the surgeon can adjust the temperature as the heating element and/or irrigation cannula is navigated around the lens to compensate for changing densities.
In some variants, using heated fluid to emulsify the lens may be preferred to a heated element. The heated fluid may have less heat loss challenges compared to the heated element because of the inflow of newly heated fluid and rapid aspiration. The heated fluid may provide a larger contact area compared to the heated element.
Systems and Methods with Tip Having One or More Temperature Controlled Elements
Alternative to or in addition with utilizing a heated fluid to emulsify or soften the lens, systems and methods are described herein that include a tip having one or more temperature controlled elements that can apply localized heat to the lens. For example,
The thermal system 200 can include a tip 202 (e.g., distal tip, distal end, end, tube). A temperature of the tip 202 of the thermal system 200 may be controlled, which can include raising (e.g., heating) and/or lowering (e.g., cooling) the temperature of the tip 202. The tip 202 may include one or more temperature controlled elements 204 (e.g., localized heating zones) that may be heated and/or cooled. The one or more temperature controlled elements 204 may be positioned at a distal face (e.g., leading plane) of the tip 202, which may be angled. The one or more temperature controlled elements 204 may include various configurations, which may at least include a ring shape, discrete circumferentially positioned elements, and/or other configurations. The one or more temperature controlled elements 204 may be heated either directly or indirectly with various energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, etc. The temperature controlled 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 controlled element 204 can enable the thermal system 200 to apply heat in a localized and targeted manner to the lens 112 that avoids damage to other features of the eye 100. The tip 202 include a circular periphery. The tip 202 can include peripheries of various shapes, which can at least include oval, polygonal (e.g., triangle, square, pentagon, etc.), irregular, and/or others. The tip 202 may be a tube.
The thermal system 200 may include hardware 210 that can enable the thermal system 200 to perform the methods described herein. The hardware 210 can include a power source (e.g., battery, rechargeable battery, disposable battery), power source interface (e.g., interface for connecting to a wired power source), temperature control unit, aspiration control unit, irrigation control unit, controller, processor, wireless communication interface, wired communication interface, memory, etc. The hardware 210 may be disposed 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 to house 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 variants, the housing 212 may include a neck portion 206 proximate the tip 202 that includes insulation properties that may protect the patient from heat.
The temperature control unit may control temperature generation and/or modulation. The control unit may control the amount of energy directed to the temperature controlled element 204 to adjust the temperature of the temperature controlled element 204, which may include adjusting energy provided by the power source and/or by way of the power source interface to the temperature controlled element 204. The temperature control unit may maintain the one or more temperature controlled elements 204 at a temperature, raise the temperature, lower the temperature, cycle the temperature, adjust the temperature based on sensor input (e.g., temperature detected at the tip 202), etc.
The aspiration control unit may control aspiration. For example, the tip 202 may include an opening 203 through which softened and/or emulsified lens 112 (e.g., proteins, biopolymers, and/or other components of the lens 112) may be aspirated (e.g., vacuumed). The aspiration control unit may initiate and cease aspiration through the opening 203. In some variants, the temperature controlled element 204 may be disposed around the opening 203, which can include circumferentially distributed around the opening 203.
The irrigation control unit may control irrigation. The thermal system 200 may include a port through which fluid (e.g., saline solution) can flow into the eye 100. The fluid may maintain the anterior chamber of the eye 100 while the lens 112 is being removed.
The thermal system 200 may include one or more user interfaces (e.g., button(s), dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), and/or slider(s)) to enable a user (e.g., surgeon) to control the thermal system 200, which may at least include activation of the thermal system 200, deactivation of the thermal system 200, heating of the one or more temperature controlled elements 204, cooling of the one or more temperature controlled element 204, initiating and/or ceasing aspiration, initiating and/or ceasing irrigation, etc. In some variants, the user may set a temperature for one or more temperature controlled elements 204. In some variants, the user may adjust a vacuum force (e.g., increase, decrease) for aspiration. In some variants, the user may adjust the flow (e.g., increase, decrease) of the fluid for irrigation.
The thermal system 200 may include one or more receptacles 208 (e.g., bag), which may be disposed inside of 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 solution) for irrigation. The one or more receptacles 208 may be disposable.
The thermal system 200 may communicate with a computing device by way of wired or wireless communication.
In some variants, the tip 202 may include other heating elements, such as one or more of the temperature controlled elements 204 described herein. In some variants, the tip 202 may not include other heating elements. As illustrated in
The thermal system 200 may include a loop 218, as illustrated in
As illustrated in
The thermo-emulsification system 300 can include a fluid reservoir 312 (e.g., chamber, compartment, vessel, bag, fluid source, tank). The fluid reservoir 312 can hold a fluid (e.g., saline solution or other fluid suitable for the eye). In some variants, the fluid reservoir 312 may be replaceable. In some variants, the fluid reservoir 312 may be for one-time use (e.g., disposable). For example, the fluid reservoir 312 may be removed after use, discarded as waste, and replaced by a new fluid reservoir 312, which may include a new supply of fluid. In some variants, the fluid reservoir 312 can be reusable. For example, the fluid reservoir 312 can be refilled while integrated with the thermo-emulsification system 300, which can include refilling the fluid reservoir 312 disposed within the housing 316 of the thermo-emulsification system 300. The fluid reservoir 312 can be removed from the housing 316 and then refilled in some instances. The fluid in the fluid reservoir 312 can be irrigated into the eye to liquify (e.g., emulsify) the lens 112.
The thermo-emulsification system 300 can include a waste reservoir 314 (e.g., chamber, compartment, vessel, bag, tank). The waste reservoir 314 can hold the waste matter aspirated from the eye when removing the lens. For example, the liquified (e.g., emulsified) lens, fragments of the lens, aqueous of the eye, and/or fluid introduced into the eye by the thermo-emulsification system 300 can be aspirated into the waste reservoir 314. The waste reservoir 314 may be replaceable. In some variants, the waste reservoir 314 may be for one time use (e.g., disposable). For example, the waste reservoir 314 may be removed after use, discarded as waste, and replaced by a new waste reservoir 314, which may be empty. In some variants, the waste reservoir 314 can be reusable. For example, the waste reservoir 314 can be drained and/or cleaned of waste matter while integrated with the thermo-emulsification system 300, which can include draining and/or cleaning the waste reservoir 314 disposed in the housing 316 of the thermo-emulsification system 300. The waste reservoir 314 can be removed from the housing 316, drained and/or cleaned, and reintegrated into the thermo-emulsification system 300.
The thermo-emulsification system 300 can include a pump system 306, which 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 the fluid reservoir 312 to the lens of the eye (e.g., inside the capsular bag), which can be referred to as irrigating the eye (e.g., capsular bag). The pump system 306 can pump waste matter from the eye (e.g., capsular bag), such as the liquified (e.g., emulsified) lens, fragments of the lens, aqueous of the eye, and/or fluid from the fluid reservoir 312 introduced into the eye, into the waste reservoir 314, which can be referred to as aspirating from the eye.
The thermo-emulsification system 300 can include a heating element and control system 308, which can also be described as the temperature adjustment system. The heating element and control system 308 can alter the temperature of the fluid delivered to the lens. In some variants, the heating element and control system 308 can raise and/or lower the temperature (e.g., heat and/or cool) of the fluid. In some variants, the heating element and control system 308 can only raise the temperature (e.g., heat) the fluid. In some variants, the heating element and control system 308 can adjust the temperature of the fluid downstream of the fluid reservoir 312. In some variants, the heating element and control system 308 can adjust the temperature of the fluid at delivery into the eye. In some variants, 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 with conduction, convection, and/or radiation.
The thermo-emulsification system 300 can include a tip 130 (e.g., cannula). The tip 130 can be disposed on a distal end of the thermo-emulsification system 300, which can include being disposed on a distal end of the housing 316. The tip 130 can be placed inside the eye and proximate the lens 112. The tip 130 can be made of variety of material, which can include metals, metal alloys, polymers, ceramics, etc. The tip 130 can include an opening 150. Fluid can be delivered from the fluid reservoir 312 to the lens 112 through the opening 150. The thermo-emulsification system 300 can include insulation 304 proximate the tip 130 to protect surrounding anatomy of the eye, which can include protecting surrounding anatomy of the eye from heat as the thermo-emulsification system 300 is being operated. The insulation 304 can be disposed circumferentially around the tip 130. In some variants, fluid can be aspirated through the opening 150 of the tip 130.
The thermo-emulsification system 300 can include a temperature sensor 310 (e.g., 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 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 prior to delivery to the lens. The temperature sensor 310 can sense the lowered temperature of the fluid resulting from heat loss prior to delivery, and in response to receiving an indication of the lowered temperature of the fluid from the temperature sensor 310, the heating element and control system 308 can raise the temperature of the fluid to accommodate for the heat loss.
The thermo-emulsification system 300 can include a port 302 (e.g., opening, aperture). The port 302 can be used to aspirate waste matter from the eye. In some variants, heated fluid and/or nonheated fluid can be delivered to the lens from the port 302. The pump system 306 can aspirate (e.g., vacuum, suck) waste matter from within the eye (e.g., capsular bag) through the port 302 and into the waste reservoir 314. The port 302 can be disposed at various positions. In some variants, the port 302 can be disposed in the insulation 304. In some variants, the port 302 can be disposed on the distal end of the tip 130. In some variants, the port 302 can be disposed on the side of the tip 130. The port 302 can be various sizes and/or shapes, which can include a circle, polygon (e.g., triangle, square, rectangle, pentagon, etc.), oval, irregular, or others.
The thermo-emulsification system 300 can irrigate and aspirate at the same time and/or different times. For example, the pump system 306 can irrigate (e.g., pump, urge) heated fluid into the eye by way of the opening 150 to liquify and/or soften the lens. The pump system 306 can aspirate (e.g., pump, vacuum, urge) the fluid irrigated into the eye, aqueous of the eye, fragments of the lens, and/or liquified lens material through the port 302 and into the waste reservoir 314.
In some variants, the thermo-emulsification system 300 can be reusable. For example, the various components (e.g., tip 130, fluid reservoir 312, waste reservoir 314, and/or others) of the thermo-emulsification system 300 can be cleaned for reuse, which may include disassembly and cleaning. In some variants, the various components (e.g., tip 130, fluid reservoir 312, waste reservoir 314, and/or others) of the thermo-emulsification system 300 can be intended for one-time use such that the various components can be removed, discarded, and replaced with new components.
In some variants, the thermo-emulsification system 300 can be intended for one-time use. For example, the thermo-emulsification system 300 can be used to remove one or both lenses from a patient and then discarded. In some variants, the thermo-emulsification system 300 can be used to only remove one lens such that removing both lenses of a patient requires two thermo-emulsification systems 300. In some variants, the thermo-emulsification system 300 can be used to remove both of a patient's lenses and then discarded, which can include replacing the fluid reservoir 312 and/or waste reservoir 314 after removing the first lens.
The thermo-emulsification system 300 can include a power source, such as one or more batteries. In some variants, the one or more batteries may be for one-time use. In some variants, the one or more batteries may be rechargeable.
The thermo-emulsification system 300 can include a power interface. The power interface can be used to recharge the battery and/or power the thermo-emulsification system 300. In some variants, the thermo-emulsification system 300 may not include a battery but, instead, rely on wired power which can supply power by way of the power interface. In some variants, the one or more batteries can be recharged with wireless charging by way of the power interface.
The thermo-emulsification system 300 can include one or more processor(s), controller(s), valve(s) (e.g., pinch valve(s), solenoid valve(s), proportional solenoid valve(s)), diverter(s), sensor(s) (e.g., flow sensor(s)), filter(s), driver(s), speaker(s), indicator light(s), user interface(s) (e.g., button(s), dial(s), knob(s), touch screen(s), switch(es)), display(s), memory with software, microphone(s), regulator(s), clock(s) (e.g., real-time clocks), internal tubing, communication interfaces (e.g., wireless and/or wired), and/or other features. The valve(s) can be used to open and/or close flow out of the fluid reservoir 312. The valve(s) can be used to open and/or close flow into the waste reservoir 314. The speaker(s), indicator lights, and/or display(s) can emit warnings for safety (e.g., the temperature sensor 310 has detected a temperature that is unsafe, the flow sensor(s) have detected an unsafe flow, the fluid in the fluid reservoir 312 is below a threshold, the waste matter in the waste reservoir 314 is above a threshold, etc.). The speaker(s), lights (e.g., indicator lights), and/or display(s) can indicate the status of the thermo-emulsification system 300 (e.g., on/off, the fluid has been heated to the appropriate temperature, battery level, mode, etc.). The user interface(s) can be used to control the thermo-emulsification system 300 (e.g., start/stop irrigation, start/stop aspiration, adjust temperature, change modes, control a light, etc.). The microphone(s) can receiver verbal instructions. The light(s) can be used to increase visibility within the eye during surgery.
The thermo-emulsification system 400 can include a handheld tool 402 (e.g., handheld instrument, tool, instrument), which can be a phaco handpiece. The handheld tool 402 can include one or more, which can include all, of the features described in reference to thermo-emulsification system 300 and/or other systems herein.
The thermo-emulsification system 400 can include a fluid reservoir 416 (e.g., fluid source, chamber, compartment, vessel, bag, tank). The handheld tool 402 can be fluidically coupled with the fluid reservoir 416. The fluid reservoir 416 can be positioned at an elevated position relative to the handheld tool 402. The fluid reservoir 416, in some variants, can be an IV bag. The fluid reservoir 416 can hold a fluid (e.g., saline solution). The fluid reservoir 416 can be fluidically coupled with the handheld tool 402 by way of an irrigation tube 406 (e.g., tube, line, conduit). The irrigation tube 406, in some variants, can be insulated to decrease 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 to liquify and/or soften the lens for removal. In some variants, the fluid reservoir 416 can be cleaned and reused. In some variants, the fluid reservoir 416 can be discarded after use and replaced with a new fluid reservoir 416 filled with fluid. In some variants, the various components of the thermo-emulsification system 400 can be intended for one-time use (e.g., for removal of both lenses of a patient or removal of one lens of a patient).
The thermo-emulsification system 400 can include a heating element and control system 414, which can also be described as the temperature adjustment system. The heating element and control system 414 can adjust the temperature of the fluid delivered to the lens. In some variants, the heating element and control system 414 can raise and/or lower the temperature (e.g., heat and/or cool) of the fluid. In some variants, the heating element and control system 414 can only raise the temperature (e.g., heat) the fluid. The heating element and control system 414 can be disposed along the irrigation tube 406. The heating element and control system 414 can be disposed along the irrigation tube 406 between the fluid reservoir 416 and the handheld tool 402. In some variants, the heating element and control system 414 can be disposed at the fluid reservoir 416 to adjust the temperature of the fluid in the fluid reservoir 416. In some variants, the heating element and control system 414 can include components (e.g., heating elements) at one of or both the fluid reservoir 416 to adjust the temperature of the fluid in the fluid reservoir 416 and along the irrigation tube 406 and/or at the handheld tool 402 to further adjust the temperature of the fluid after leaving the fluid reservoir 416. The heating element and control system 414 can adjust the temperature of the fluid with conduction, convection, and/or radiation.
The thermo-emulsification system 400 can include one or more temperature sensors (e.g., thermocouples) at various positions. For example, the thermo-emulsification system 400 can include a temperature sensor at the fluid reservoir 416 to measure the temperature of the fluid held in the fluid reservoir 416. The thermo-emulsification system 400 can include one or more temperature sensors along the irrigation tube 406. The thermo-emulsification system 400 can include one or more temperature sensors at the heating element and control system 414. The thermo-emulsification system 400 can include a temperature sensor 412 (e.g., thermocouple) along the irrigation tube 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 at the temperature sensor 412 can be a factor in determining the quantity of energy to be output by the heating element and control system 414 to adjust the temperature of the fluid to a desired temperature. The thermo-emulsification system 400 can include a temperature sensor 410 at the heating element and control system 414. The thermo-emulsification system 400 can include the temperature sensor 310 at the tip 130 (e.g., cannula). The temperatures sensed by the various temperature sensors of the thermo-emulsification system 400 can be used to control the energy output by the heating element and control system 414 to adjust the temperature of the fluid.
The thermo-emulsification system 400 can include one or more valves. For example, the thermo-emulsification system 400 can include a valve 418, which can be a pinch valve. The valve 418 can be manipulated to start and stop flow of the fluid from the fluid reservoir 416 to the handheld tool 402. The valve 418 or another component can adjust the flow rate of the fluid from the fluid reservoir 416 to the handheld tool 402. In some variants, the handheld tool 402 can include a valve or other component to adjust the flow rate of the fluid into the eye. The valve 418 can be manually operated or electronically operated. The valve 418 may automatically close if a triggering event occurs (e.g., a sensed temperature is above or below a threshold).
The thermo-emulsification system 400 can include a waste reservoir 424 (e.g., chamber, compartment, vessel, bag, tank). The waste reservoir 424 can be fluidically coupled with the handheld tool 402. The waste reservoir 424 can be fluidically coupled with the handheld tool 402 by way of an aspiration tube 404 (e.g., tube, line, conduit). The aspiration tube 404, in some variants, can be insulated. In some variants, the thermo-emulsification system 400 can include a temperature sensor 408 along the aspiration tube 404 to sense the temperature of the waste matter flowing therein. The thermo-emulsification system 400 can include a temperature sensor at the waste reservoir 424. The waste reservoir 424 can hold the waste matter aspirated from the eye when removing the lens. For example, the liquified (e.g., emulsified) lens, fragments of the lens, aqueous of the eye, and/or fluid introduced into the eye by the thermo-emulsification system 400 can be aspirated into the waste reservoir 424. The waste reservoir 424 can be replaceable. The waste reservoir 424 may be for one-time use (e.g., disposable). For example, the waste reservoir 424 may be removed after use, discarded as waste, and replaced by a new waste reservoir 424, which may be empty. In some variants, the waste reservoir 414 can be reusable. For example, the waste reservoir 414 can be drained and/or cleaned of waste matter while integrated with the thermo-emulsification system 400. The waste reservoir 424 can be removed from the thermo-emulsification system 400, drained and/or cleaned, and reintegrated into the thermo-emulsification system 400.
The thermo-emulsification system 400 can include a pump system 422, which can include one or more pumps. The pump system 422 can pump the waste matter from the eye and into the waste reservoir 424 (e.g., into the handheld tool 402, through the aspiration tube 404, and into the waste reservoir 424). The pump system 422 can be part of a phaco machine 420. In some variants, the aspiration tube 404, temperature sensor 408, and/or waste reservoir 424 can be components for the phaco machine 420 that cooperate with the thermo-emulsification system 400. In some variants, the pump system 422 can pump fluid from the fluid reservoir 416 and into the eye (e.g., through the irrigation tube 406, into the handheld tool 402, and into the eye). In some variants, the fluid in the fluid reservoir 416 can flow from gravity rather than the pump system 422. For example, the fluid reservoir 416 can be disposed at an elevated position such that gravity causes the fluid to flow out of the fluid reservoir 416, through the irrigation tube 406, and into the handheld tool 402 for delivery. As described herein, the thermo-emulsification system 400 can include a valve (e.g., valve 418) and/or other flow regulator to adjust the flow of the fluid. In some variants, one or more valves (e.g., one-way valve) can be disposed along the aspiration tube 404, within the handheld tool 402, and/or at the waste reservoir 424 to prevent backflow of the waste matter.
The thermo-emulsification system 400 can irrigate and aspirate at the same time and/or different times. In some variants, the thermo-emulsification system 400 can be reusable. For example, the various components (e.g., tip 130, fluid reservoir 416, waste reservoir 424, and/or others) of the thermo-emulsification system 400 can be cleaned for reuse, which may include disassembly and cleaning. In some variants, the various components (e.g., tip 130, fluid reservoir 416, waste reservoir 424, and/or others) of the thermo-emulsification system 400 can be intended for one-time use such that the various components can be removed, discarded, and replaced with new components.
In some variants, the thermo-emulsification system 400 or components thereof can be intended for one-time use. For example, the thermo-emulsification system 400 or components thereof can be used to remove one or both lenses from a patient and then discarded. In some variants, the thermo-emulsification system 400 or components thereof can be used to only remove one lens such that removing both lenses of a patient requires two thermo-emulsification systems 400 or replacement of some of the components. In some variants, the thermo-emulsification system 400 or components thereof can be used to remove both of a patient's lenses and then discarded, which can include replacing the fluid reservoir 416 and/or waste reservoir 424 after removing the first lens.
The thermo-emulsification system 400, which can include components thereof, can include a power source, such as one or more batteries. In some variants, the one or more batteries may be for one-time use. In some variants, the one or more batteries may be rechargeable.
The thermo-emulsification system 400 can include a power interface. The power interface can be used to recharge the battery and/or power the thermo-emulsification system 400. In some variants, the thermo-emulsification system 400 may not include a battery but, instead, rely on wired power which can supply power by way of the power interface. In some variants, the one or more batteries can be recharged with wireless charging by way of the power interface.
The thermo-emulsification system 400 can include one or more processor(s), controller(s), valve(s) (e.g., pinch valve(s), solenoid valve(s), proportional solenoid valve(s)), diverter(s), sensor(s) (e.g., flow sensor(s)), filter(s), driver(s), speaker(s), indicator light(s), user interface(s) (e.g., button(s), dial(s), knob(s), touch screen(s), switch(es)), display(s), memory with software, microphone(s), regulator(s), clock(s) (e.g., real-time clocks), tubing, communication interfaces (e.g., wireless and/or wired), and/or other features. The speaker(s), indicator lights, and/or display(s) can emit warnings for safety (e.g., a temperature sensor has detected a temperature that is unsafe, a flow sensor(s) has detected an unsafe flow, the fluid in the fluid reservoir 416 is below a threshold, the waste matter in the waste reservoir 424 is above a threshold, etc.). The speaker(s), lights (e.g., indicator lights), and/or display(s) can indicate the status of the thermo-emulsification system 400 (e.g., on/off, the fluid has been heated to the appropriate temperature, battery level, mode, etc.). The user interface(s) can be used to control the thermo-emulsification system 400 (e.g., start/stop irrigation, start/stop aspiration, adjust temperature, change modes, control a light, etc.). The microphone(s) can receiver verbal instructions. The light(s) can be used to increase visibility within the eye during surgery.
The thermo-emulsification system 500 can include a device interface 580 (e.g., interface). The device interface 580 can interface with a tool (e.g., handheld tool 402, phaco handpiece) that delivers the heated fluid to the eye and/or aspirates waste material from the eye.
The thermo-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, vessel, bag, tank). The heated tank 558 can hold a fluid (e.g., saline solution). At the exit of the heated tank 558 and/or downstream from the heated tank 558, the delivery fluid system 556 can include a filter 562, pump 564, flow meter 566, and/or valve 568 (e.g., proportional solenoid valve). The filter 562 can capture unwanted particles. The pump 564 can draw fluid out of the heated tank 558 and urge the fluid down a fluid delivery line 582 (e.g., tube, conduit) to the device interface 580. The flow meter 566 can detect the flow rate and/or other characteristics of the fluid. The valve 568 can open and close to stop, allow, and/or adjust the flow of fluid therethrough. The detected flow rate and/or other characteristics of the fluid can be used to control the pump 564 to adjust the flow rate of the fluid and/or adjust the valve 568 to adjust the flow rate of the fluid through the fluid delivery line 582 to the device interface 580.
The thermo-emulsification system 500 can include a thermal control system 534. The thermal control system 534 can adjust the temperature of the fluid delivered to the eye. For example, the thermal control system 534 can adjust the temperature of the fluid (e.g., heat the fluid) in the heated tank 558. The thermal control system 534 can include a heater 540 (e.g., variable current driver). The heater 540 can include a heating element 544 that can heat the fluid in the heated tank 558, which can include fluid exiting the heated tank 558. The thermal control system 534 can include a temperature sensor interface 536 (e.g., T-type thermocouple interface) and/or safety sensor 538. The thermal control system 534 can include a temperature sensor 542 (e.g., thermocouple) that operatively couples with the temperature sensor interface 536. The temperature sensor 542 can sense the temperature of the fluid in the heated tank 558, which can be used by the thermal control system 534 to adjust the energy (e.g., current) output by the heater 540 to adjust the temperature of the fluid in the heated tank 558 to a desired target temperature. The temperature sensor (thermocouple) 542 can be disposed at the heated tank 558, which can include in the heated tank 558.
The thermo-emulsification system 500 can include a return fluid system 570 (e.g., waste matter system, aspiration system). The return fluid system 570 can include a capture tank 572 (e.g., chamber, compartment, vessel, bag, tank). The capture tank 572 can hold the waste matter aspirated from the eye when removing the lens. For example, the liquified (e.g., emulsified) lens, fragments of the lens, aqueous of the eye, and/or fluid introduced into the eye by the thermo-emulsification system 500 can be aspirated into the capture tank 572. The return fluid system 570 can include a pump 574, flow meter 576, and/or valve 578 (e.g., proportional solenoid valve). The pump 574 can aspirate (e.g., urge, vacuum) waste matter from the eye, into the handheld device, through the device interface 580, through a fluid return line 584 (e.g., tube, conduit), and into the capture tank 572. The flow meter 576 can be used to measure the flow rate and/or other characteristics of the waste matter through the fluid return line 584. The valve 578 can open and/or close to stop, allow, and/or adjust the flow of fluid therethrough to the capture tank 572. In some variants, the valve 578 is a one way valve to prevent backflow. The detected flow rate and/or other characteristics of the fluid can be used to control the pump 574 to adjust the flow rate of the fluid and/or adjust the valve 578 to adjust the flow rate of the fluid through the fluid return line 584 to the capture tank 572.
The thermo-emulsification system 500 can include a fluid control system 546. The fluid control system 546 can control the flow of fluid through the thermo-emulsification system 500. The fluid control system 546 can include one or more pump drivers 548, flow safety module 550, flow sensor interface 552, and/or valve actuation controller 554. The pump drivers 548 can operate the pump 564 and/or pump 574. The flow sensor interface 552 can communicate with the flow meter 566 and/or flow meter 576 to receive indications of the sensed flow rates. The valve actuation controller 554 can be used to control the valve 568 and/or valve 578. The pump drivers 548 and/or valve actuation controller 554 can adjust the flow rate or even stop flow when certain conditions are met. For example, if the flow is too high (e.g., above a threshold) in the fluid delivery line 582 and/or fluid return line 584, the pump drivers 548 and/or valve actuation controller 554 can control the pump 564, pump 574, valve 568, and/or valve 578 to decrease flow to a target. If the flow is too low (e.g., below a threshold) in the fluid delivery line 582 and/or fluid return line 584, the pump drivers 548 and/or valve actuation controller 554 can control the pump 564, pump 574, valve 568, and/or valve 578 to increase flow to a target.
The thermo-emulsification system 500 can include a power system 502 to power the thermo-emulsification system 500. The power system 502 can include a battery 508, which can be rechargeable. The power system 502 can include a charging interface 510. The charging interface 510 can interface with a charger device 514 (e.g., cable) to supply power from a power source 516 (e.g., power outlet) to charge the battery 508 and/or supply power directly to the thermo-emulsification system 500. The power system 502 can include a power management module 512, a voltage regulator 506, and/or gauge 504 (e.g., power gauge, power indicator, battery power level indicator).
The thermo-emulsification system 500 can include a control system 518. The control system 518 can include a micro controller 520, real-time clock 522 (e.g., RTC), and/or memory 524. The real-time clock 522 can be used to identify triggering events for the thermo-emulsification system 500 to respond to. For example, the thermo-emulsification system 500 may slow the flow rate in the fluid delivery line 582 if the flow rate is above a threshold for a period of time (e.g., one second). The control system 518 may interface with a data analysis system 600. The data analysis system 600 can be used to log and analyze data regarding the thermo-emulsification system 500. The data analysis system 600 can include a port 606 by which the thermo-emulsification system 500 can connect. The data analysis system 600 can include an input 604, through which the data analysis system 600 can connect to other computing systems. Data log 602 displays a graph of the fluid temperature in the heated tank 558 as a function of time.
The thermo-emulsification system 500 can include a user interface system 526. The user interface system 526 can include one or more button(s) 528, which can at least be used to adjust temperature of the fluid, start/stop irrigation and/or aspiration, change modes, adjust flow rates, open and/or shut valves, power on/off, and/or other adjustments. The user interface system 526 can, in some variants, include dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), slider(s), and/or other features. The user interface system 526 can include indicator(s) 530 (e.g., indicator lights, such as LEDs). The indicator(s) 530 can visually indicate when the thermo-emulsification system 500 is ready for operation and/or not ready for operation. The indicator(s) 530 can visually indicate when the thermo-emulsification system 500 is aspirating and/or irrigating. The indicator(s) 530 can indicate the charge level of the battery 508. The indicator(s) 530 can indicating when the thermo-emulsification system 500 is communicating with another computing system (e.g., transmitting data). The indicator(s) 530 can emit warnings to the surgeon. The indicator(s) 530 can emit various colors and/or patterns of light. The user interface system 526 can include a speaker(s) 532 (e.g., buzzer), which can emit audible sounds to communicate warnings, alert of safety issues, and/or emit sounds when various actions are performed (e.g., power on/off). In some variants, the user interface system 526 can include one or more displays, touchscreens, microphones for spoken commands, etc. In some variants, the indicator(s) 530, speaker(s) 532, display, touchscreen, etc. can indicate the fill level of the heated tank 558 and/or capture tank 572, which can include warning when the fill level has dropped below or risen above a threshold. In some variants, the indicator(s) 530, speaker(s) 532, display, touchscreen, etc. can communicate an indication of how long the thermo-emulsification system 500 has been in use, which can indicate to a surgeon how much longer the eye can safely be irrigated with heated fluid.
The thermo-emulsification system 500, in some variants, can include a wired communication interface and/or a wireless communication interface to communicate with other computing devices. The thermo-emulsification system 500 can, in some variants, include a light to illuminate the eye during surgery.
An irrigation tip 700 (e.g., cannula) can be introduced into the eye 100 and to the lens 112 through one microincision. An aspiration tip 704 (e.g., cannula) can be introduced into the eye 100 and to the lens 112 through another microincision. The irrigation tip 700 and aspiration tip 704 can be disposed generally opposite each other (e.g., about one hundred and eighty degrees apart from each other). Fluid heated to one of the temperature ranges described herein (e.g., 64-70 degrees, 66-70 degrees Celsius, 68-70 degrees Celsius) can be delivered from an opening 702 (e.g., distal opening, aperture) of the irrigation tip 700 to the lens 112. The opening 702 can be disposed on a distal end of the irrigation tip 700. The heated fluid can liquify the lens 112 as described herein. The heated fluid can penetrate the lens 112. The heated fluid can apply low pressure on the lens 112.
The liquified lens 112 can be aspirated (e.g., vacuumed, sucked) through an opening 706 (e.g., distal opening, aperture) of the aspiration tip 704 for removal. The opening 706 can be disposed on a distal end of the aspiration tip 704. The aspiration tip 704 can aspirate waste material (e.g., liquified lens 112, aqueous of the eye 100, fragments of the lens, and/or fluid introduced into the eye 100 by the irrigation tip 700). The aspiration tip 704 can be disposed proximate the irrigation tip 700, which can include opposite each other, to quickly aspirate heated fluid and/or liquified lens 112 from the eye 100. The irrigation tip 700 and aspiration tip 704 can be positioned such that the opening 702 of the irrigation tip 700 and the opening 706 of the aspiration tip 704 generally face each other. The aspiration tip 704 can quickly aspirate the heated fluid and/or liquified lens 112 to keep heat localized.
As described herein, the fluid can be heated in a tank or the like upstream of the irrigation tip 700. For example, as illustrated in
In some variants, 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 liquified lens 112.
In some variants, the irrigating and aspiration can be performed in series using the same incisions in the cornea 102 and/or capsular bag 110. For example, the irrigation tip 700 can be introduced to liquify the lens 112 with heated fluid. The irrigation tip 700 can then be retracted and the aspiration tip 704 be introduced to aspirate the liquified lens and heated fluid.
With the lens 112 removed, an intraocular lens can be introduced into the eye 100. For example, the intraocular lens can be placed into the capsular bag 110. The intraocular lens can be sized to fill the capsular bag, similar to the natural lens.
The irrigation tip 700 and the aspiration tip 704 can be introduced into the eye 100 through the microincision in the cornea 102. The irrigation tip 700 and the aspiration tip 704 can advance to the lens 112 through the cut in the anterior of the capsular bag 110. The irrigation tip 700 and the aspiration tip 704 can be juxta positioned. The irrigation tip 700 and the aspiration tip 704 can be positioned parallel relative to each other (e.g., the axes of the irrigation tip 700 and the aspiration tip 704 can be substantially parallel relative to each other). The irrigation tip 700 and the aspiration tip 704 can contact each other along longitudinal sides. The opening 702 of the irrigation tip 700 can be positioned adjacent the opening 706 of the aspiration tip 704. The axes of the opening 702 and the opening 706 can be substantially parallel.
In some variants, the irrigation tip 700 and aspiration tip 704 can be introduced simultaneously. In some variants, the irrigation tip 700 and aspiration tip 704 can be introduced in series. In some variants, the irrigation tip 700 and aspiration tip 704 can be joined together, which can include longitudinal sides being joined together.
As shown in
A coaxial system 701 (e.g., coaxial cannulas, coaxial tips) can be advanced into the eye 100 through the incision in the cornea 102. The coaxial system 701 can be advanced to the lens 112 through the incision in the anterior of 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
As illustrated in
The heated fluid 708 can flow out of the opening 714 and to the lens 112 to liquify the lens 112. The outer tip 712 can aspirate (e.g., vacuum, suck) the heated fluid 708 and liquified lens 112 through an internal lumen 722, which can include the space between an outer periphery of the inner tip 720 and an inner wall of the outer tip 712 defining the internal lumen 722. The aspirated material 710 can flow to a waste reservoir. The heated fluid 708 and/or liquified lens 112 can be aspirated through the opening 714 into the internal lumen 722 of the outer tip 712. In some variants, the distal end of the outer tip 712 defining the opening 714 can contact the lens 112.
As illustrated in
As illustrated in
As illustrated in
An aspiration tip 734 (e.g., cannula) can be introduced into the eye 100 through the microincision in the cornea 102. The aspiration tip 734 can be advanced to the lens 112 through the cut in the anterior of the capsular bag 110. The aspiration tip 734 can include a heated element 736 (e.g., heated portion). The heated element 736 can be disposed at a distal end of the aspiration tip 734. For example, as shown in
As illustrated in
Various further features of the system and methods described herein are detailed below. In some variants, the heated fluid and/or heated elements described herein can be used to cut an incision through the cornea and/or capsular bag to access the lens of the eye. The heating of fluid can be done externally and attached as a module to current irrigation/aspiration setups (e.g., phaco machine). Heating of fluid can be performed in a syringe barrel as a handheld unit can also have an irrigation/aspiration setup. Heating of the fluid can be performed at any location in the systems and methods described herein so long as the temperature of the fluid at the lens is within the ranges described herein. As described herein, temperature sensors (e.g., thermocouples) can be disposed throughout a system and/or in the eye to enable a closed loop system to ensure temperature modulation is controlled. Various sources of heating can be employed to heat the heating elements and/or fluid, which can at least include (electrical, radio-frequency, ultrasound, LASER, microwave, heat gun, immersion heater, chemical reaction, gas, nuclear, and/or others). In some variants, the distal tips and/or body of the irrigation and/or aspiration cannulas described herein can be insulated. The heated fluid can be introduced into the lens by way of a variety of techniques, which at least can include starting at the cortex/nucleus of the lens to dissipate/emulsify from the inside out, use injection as a method to break up the lens into pieces/fragments, or start from the periphery to dig into the lens and aspirate/extract. In some variants, the irrigation cannula can be inserted into the core of the lens and then irrigate heated fluid to emulsify from the core out. The systems and methods can enable surgeons to use microincisions into the capsular bag, which could preserve the bag and/or zonules of the eye. Localized heating by way of convection (e.g., heated fluid) can enable emulsification of the lens 112 (e.g., cataract proteins) without disturbing nearby tissue. The methods of removing the lens described herein with heated elements and/or heated fluid can be performed in a few seconds to less than one minute while preserving the capsular bag and zonules. In some variants, the systems herein can include a handpiece that is either independent or controls by way of the phaco handpiece/heater setup. The irrigation described herein can be low pressure to reduce excess heat transfer into tissue. The system and methods described herein can be used in a robotic surgery.
The irrigation handpiece 1000 can include a port 1010 (e.g., inlet) through which fluid (e.g., saline solution) can be delivered to the irrigation handpiece 1000. In some variants, heated fluid can be delivered to the irrigation handpiece 1000. In some variants, fluid can be delivered to the irrigation handpiece 1000 and the irrigation handpiece 1000 can heat the fluid prior to delivery in the eye. The port 1010 can be disposed on a proximal portion of the irrigation handpiece 1000. The port 1010 can be fluidically coupled to a reservoir (e.g., container, bag, IV bag, vessel, etc.) of fluid (e.g., saline solution).
The irrigation handpiece 1000 can include an irrigation tube 1002 (e.g., tube, cannula, needle). The irrigation tube 1002 can be inserted through the cornea 102 and into the capsular bag 110 to direct heated fluid at the lens 112. The irrigation tube 1002 can be elongate. The irrigation tube 1002 can include a curved portion. For example, the irrigation tube 1002 can include a proximal portion that is straight and then curve to 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 a proximal portion. The irrigation tube 1002 can be a variety of sizes (e.g., diameters), which can at least include 0.1-3.0 millimeters, 1.0-2.5 millimeters, or less than 2.0 millimeters. The irrigation tube 1002 can be disposed on a distal portion of the irrigation handpiece 1000.
The irrigation tube 1002 can include one or more outlets 1006 (e.g., openings, holes), which can at least include one, two, three, four or more outlets 1006. The one or more outlets 1006 can be disposed at a distal portion of the irrigation tube 1002. The one or more outlets 1006 can be disposed through a peripheral wall of the irrigation tube 1002. For example, in some variants, a distal end of the irrigation tube 1002 can be closed and two outlets 1006 can be disposed in the peripheral wall of the irrigation tube 1002, which can include the two outlets 1006 being disposed at about one hundred and eighty degrees apart from each other. Fluid received through the port 1010 of the irrigation handpiece 1000 can flow out of the irrigation tube 1002 by way of the one or more outlets 1006.
The irrigation handpiece 1000 can include a distal portion 1004 (e.g., end portion, distal piece, end piece, connector, tips, distal tips). The irrigation tube 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., housing) of the irrigation handpiece 1000, which can include being removably coupled to the body 1008. In some variants, the distal portion 1004 can be a disposable component (e.g., disposable end piece) that is replaced between surgeries. In some variants, the irrigation handpiece 1000 can be disposable and replaced between surgeries. The body 1008 can be ergonomically designed to be held by a hand 1020. The body 1008 can house one or more features of the irrigation handpiece 1000, which can at least include one or more heaters (e.g., heating devices), fluid lines (e.g., tubes, lumens, hoses, etc.) to direct a flow of fluid received through the port 1010, valves, conduits (e.g., wires), processors, controllers, power interfaces, batteries, memories, 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.
The irrigation handpiece 1000 can include an interface 1014 (e.g., port, connector) to couple with a cable 1012. The cable 1012 can provide electrical power to the irrigation handpiece 1000. Electrical power can be provided to the irrigation handpiece 1000 from a console (e.g., power source, computing device) by way of the cable 1012. The cable 1012 can communicate data, which can include temperature data, flow rate data, instructions, etc., between the irrigation handpiece 1000 and the console. In some variants, data can be communicated wirelessly between the irrigation handpiece 1000 and the console.
The irrigation handpiece 1000 can include a user interface 1016 (e.g., toggle, switch, button, dial, slider, etc.). The user interface 1016 can be used to control the flow of heated fluid out of the irrigation tube 1002. In some variants, the user interface 1016 can be manipulated to stop or start the flow of heated fluid out of the irrigation tube 1002. In some variants, as a default, fluid may flow out of the irrigation tube 1002 to maintain pressure in the capsular bag 110 during cataract surgery but, upon interacting with the user interface 1016 (e.g., interacting with, pushing, pulling, and/or switching the user interface 1016), heated fluid may flow out of the irrigation tube 1002 to emulsify the lens 112. In some variants, the user interface 1016 can be manipulated to adjust a temperature of the heated fluid.
The irrigation handpiece 1000 can include one or more indicators 1018 (e.g., lights, speakers, displays, etc.). The one or more indicators 1018 can indicate a status of the irrigation handpiece 1000. For example, the one or more indicators 1018 can indicate when the irrigation handpiece 1000 is receiving electrical power. The one or more indicators 1018 can indicate when fluid heated to emulsify the lens 112 is flowing out of the irrigation tube 1002 and/or when it is not. In some variants, the one or more indicators 1018 can indicate when a temperature at the irrigation tube 1002 is above or below a threshold.
The irrigation handpiece 1000 can include any feature of any other irrigation device, aspiration device, thermal device, and/or other device or system described herein. In some variants, the irrigation handpiece 1000 can aspirate as well.
The irrigation handpiece 1022 can include an user interface 1017 (e.g., toggle, switch, button, dial, slider, etc.). The user interface 1017 can be used to turn the irrigation handpiece 1022 on and off (e.g., activate the irrigation handpiece 1022).
The aspiration handpiece 1024 can include a port 1034 (e.g., outlet) through which fluid, heated fluid, and/or emulsified lens 112 can leave (e.g., be aspirated out of) the irrigation handpiece 1000. The port 1034 can be disposed on a proximal portion of the aspiration handpiece 1024. A vacuum can aspirate material out of the aspiration handpiece 1024 by way of the port 1034. The port 1034 can be fluidically coupled to a container, such as a vacuum canister (e.g., separator). The port 1034 can be fluidically coupled to a wall vacuum.
The aspiration handpiece 1024 can include an aspiration tube 1026 (e.g., tube, cannula, needle). The aspiration tube 1026 can be inserted through the cornea 102 and into the capsular bag 110 to aspirate material such as fluid, heated fluid, and/or emulsified lens 112. The aspiration tube 1026 can be elongate. The aspiration tube 1026 can include a curved portion. For example, the aspiration tube 1026 can include a proximal portion that is straight and then curve to a distal portion that is angled relative to the proximal portion. The aspiration tube 1026 can include a distal portion that is angled relative to a proximal portion. The aspiration tube 1026 can be a variety of sizes (e.g., diameters), which can at least include 0.1-3.0 millimeters, 1.0-2.5 millimeters, or less than 2.0 millimeters. The aspiration tube 1026 can be disposed on a distal portion of the aspiration handpiece 1024.
The aspiration tube 1026 can include one or more inlets 1028 (e.g., openings, holes), which can at least include one, two, three, four or more inlets 1028. The one or more inlets 1028 can be disposed at a distal portion of the aspiration tube 1026. The one or more inlets 1028 can be disposed through a peripheral wall of the aspiration tube 1026. For example, in some variants, a distal end of the aspiration tube 1026 can be closed and two inlets 1028 can be disposed in the peripheral wall of the aspiration tube 1026, which can include the two inlets 1028 being disposed at about one hundred and eighty degrees apart from each other. Material aspirated through the one or more inlets 1028 can flow out (e.g., be aspirated out of) of the aspiration handpiece 1024 by way of the port 1034.
The aspiration handpiece 1024 can include a distal portion 1030 (e.g., end portion, distal piece, end piece, connector, tips, distal tips). 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., housing) of the aspiration handpiece 1024, which can include being removably coupled to the body 1032. In some variants, the distal portion 1030 can be a disposable component (e.g., disposable end piece) that is replaced between surgeries. In some variants, the body 1032 can be ergonomically designed to be held by a hand 1020. The body 1032 can house one or more features of the aspiration handpiece 1024, which can at least include one or more valves, fluid lines (e.g., tubes, lumens, hoses, etc.), conduits (e.g., wires), processors, controllers, power interfaces, batteries, memories, 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.
The aspiration handpiece 1024 can include a user interface 1036 (e.g., toggle, switch, button, dial, slider, etc.). The user interface 1036 can be used to control aspiration by the aspiration handpiece 1024. In some variants, the user interface 1036 can be manipulated to stop or start aspiration. In some variants, the user interface 1036 can be manipulated (e.g., interacted with, pushed, pulled, and/or switched) to adjust aspiration (e.g., increase or decrease flow rates, pressure, etc.).
In some variants, the aspiration handpiece 1024 can include one or more indicators (e.g., lights, speakers, displays, etc.). The one or more indicators can indicate a status of the aspiration handpiece 1024, which can include a blocked status. For example, the one or more indicators can indicate when the aspiration handpiece 1024 is in a configuration for aspirating (e.g., a valve is open). The one or more indicators can indicate when a temperature at the aspiration tube 1026 is above or below a temperature threshold.
As shown, a reservoir 1044 (e.g., container, bag, IV bag, vessel, etc.) can supply fluid (e.g., saline solution) to the irrigation handpiece 1040. An inlet line 1042 (e.g., inlet tubing, conduit, hose) can direct a flow of fluid from the reservoir 1044 to the irrigation handpiece 1040. In some variants, one or more valves can be disposed at the outlet of the reservoir 1044 and/or along the inlet line 1042 to selectively stop a flow of fluid to the irrigation handpiece 1040. In some variants, one or more flow regulators, which can be adjustable (e.g., automatically adjustable) can be disposed at the outlet of the reservoir 1044 and/or along the inlet line 1042 to adjust a flow of fluid to the irrigation handpiece 1040.
The inlet line 1042 can split into a first fluid line 1046 (e.g., tubing, conduit, hose) and second fluid line 1048 (e.g., tubing, conduit, hose). The split can be outside or inside the body of the irrigation handpiece 1040. The first fluid line 1046 can direct fluid from the reservoir 1044 to a valve 1052. The second fluid line 1048 can direct fluid from the reservoir 1044 to a heater 1050 (e.g., 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., values between 64-70 degrees Celsius). The heater 1050 can heat the fluid to a precise temperature regardless of the inflow temperature. In some variants, the heater 1050 can heat the fluid above temperatures described herein to accommodate for heat loss prior to delivery at the lens 112 such that the heated fluid, when delivered at the lens 112, is at the temperatures described herein (e.g., values between 64-70 degrees Celsius).
In some variants, the valve 1052 can alternate between permitting a flow through the first fluid line 1046 while stopping a flow through the second fluid line 1048 and permitting a flow through the second fluid line 1048 while stopping a flow through the first fluid line 1046. For example, the irrigation handpiece 1040 can include an user interface 1060 (e.g., toggle, switch, button, dial, slider, etc.) that can be interacted with (e.g., pushed, pulled, pressed, rotated, etc.) to reconfigure the valve 1052 to permit or stop flow through the first fluid line 1046 and second fluid line 1048. For example, a surgeon performing cataract surgery using the irrigation handpiece 1040 can interact with the user interface 1060 to configure the valve 1052 to stop flow through the first fluid line 1046 and permit flow through the second fluid line 1048 to direct heated fluid through the outlet line 1062 to the irrigation tube for delivery to the lens 112. In some variants, the valve 1052 can be manipulated (e.g., actuated) to stop the flow of fluid through the first fluid line 1046, permit the flow of fluid through the first fluid line 1046, stop the flow of fluid through the second fluid line 1048, and/or permit the flow of fluid through the second fluid line 1048.
When the valve 1052 is configured to permit 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 an outlet line 1062 (e.g., tubing, conduit, hose) of the irrigation handpiece 1040 without being routed to the heater 1050 (e.g., without being heated) to be delivered within the capsular bag 110 by way of an irrigation tube of the irrigation handpiece 1040, which can enable 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 permitting 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 to be delivered to the lens 112 within the capsular bag 110 by way of an irrigation tube of the irrigation handpiece 1040, which can enable the irrigation system 1038 to emulsify the lens 112 for aspiration. The heater 1050 can adjust (e.g., increase, decrease) energy transferred to the fluid in the second fluid line 1048 to alter the temperature of the fluid. The heater 1050 can adjust energy transferred to the fluid in the second fluid line 1048 based on a sensed temperature at the irrigation tube of the irrigation handpiece 1040 and/or other location. For example, if the sensed temperature at the irrigation tube is above a threshold, the heater 1050 can decrease energy transferred to the fluid. If the sensed temperature at the irrigation tube is below a threshold, the heater 1050 can increase energy transferred to the fluid.
As illustrated, the aspiration system 1069 can include a vacuum line 1074 (e.g., tubing, conduit, hose) that is fluidically coupled with the aspiration handpiece 1094. The vacuum line 1074 can supply a vacuum force (e.g., aspiration force, sucking force) to the aspiration handpiece 1094. As described herein, the aspiration handpiece 1094 can include an aspiration tube that can be introduced into the capsular bag 110 to aspirate 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 the aspirated material can flow into the aspiration handpiece 1094.
The aspiration handpiece 1094 can include a valve 1104 (e.g., spring valve) that can stop or permit the vacuum force (e.g., aspiration force, sucking force) from the vacuum line 1074 aspirating material through the aspiration tube disposed in the capsular bag 110. The valve 1104 can include an obstruction 1096 (e.g., barrier, 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., flow path) to permit flow through the aspiration handpiece 1094, which can include fluidically connecting the aspiration tube with the vacuum force of the vacuum line 1074. The valve 1104 can include a spring 1098 (e.g., resilient member). The spring 1098 can bias the valve 1104 to position the obstruction 1096 at the inlet line 1070 to stop flow through the aspiration handpiece 1094. The aspiration handpiece 1094 can include the user interface 1060 (e.g., toggle, switch, button, dial, slider, etc.) that can be interacted with (e.g., pushed, pulled, pressed, rotated, etc.) to overcome the biasing force of the spring 1098 to position the fluid opening 1095 at the inlet line 1070 to permit flow through the aspiration handpiece 1094 (e.g., fluidically connect the aspiration tube with the vacuum force of the vacuum line 1074).
The vacuum line 1074 can include a vacuum canister 1086 (e.g., separator canister, container), vacuum regulator 1088, vacuum gauge 1090, and/or vacuum source 1092 (e.g., wall vacuum, pump). The vacuum source 1092 can supply the vacuum force to aspirate material with the aspiration handpiece 1094. The vacuum canister 1086 can collect material (e.g., fluid, emulsified lens 112, etc.) aspirated by the aspiration handpiece 1094. The vacuum regulator 1088 can maintain vacuum pressures, which can be selectively adjusted. The vacuum gauge 1090 can indicate the vacuum pressure in the vacuum line 1074.
As illustrated in
The irrigation handpiece 1108 can include a valve 1112 (e.g., spring valve). The valve 1112 can include an opening 1116 (e.g., flow path). The opening 1116 can be positioned to fluidically connect the irrigation tube 1002 with the first fluid line 1046 or the second fluid line 1048. The valve 1112 can include a spring 1122 (e.g., resilient member) that can bias the opening 1116 to be positioned at the first fluid line 1046 to fluidically connect the first fluid line 1046 with the irrigation tube 1002 such that fluid flows through the irrigation handpiece 1108 without be routed to the heater 1050. An obstruction 1120 (e.g., barrier, flange, wall) of the valve 1112 can be disposed at the second fluid line 1048 to block flow.
The user interface 1060 can be interacted with (e.g., pushed) to overcome the biasing force of the spring 1122 to position the opening 1116 at the second fluid line 1048 to fluidically connect the second fluid line 1048 with the irrigation tube 1002 such that fluid heated by the heater 1050 flows out of the one or more outlets 1006 of the irrigation tube 1002 to emulsify the lens 112. An obstruction 1118 (e.g., barrier, flange, wall) of the valve 1112 can be disposed at the first fluid line 1046 to block flow.
The irrigation handpiece 1108 can include one or more temperature sensors (e.g., thermocouples), which can be used to monitor temperatures throughout the irrigation handpiece 1108. The sensed temperatures can be used to control energy output by the heater 1050 to maintain the temperature of the heated fluid at the outlet 1006 of the irrigation tube 1002 within a range. The temperature sensors can trigger safety protocols if unsafe temperatures are detected, which can include decreasing energy output by the heater 1050, emitting an alarm notification, and/or stopping the flow of fluid in second fluid line 1048.
The irrigation handpiece 1108 can include a temperature sensor 1128 at the outlet 1006 to monitor a temperature at the location of delivering the heated fluid to the lens 112 for emulsification. The irrigation handpiece 1108 can include a temperature sensor 1126 at the second fluid line 1048 downstream of the heater 1050 but prior to the irrigation tube 1002, which can include upstream of the valve 1112. If the temperature sensed at the outlet 1006 is less than a threshold, the energy output by the heater 1050 can be increased. In some variants, a comparison between the temperatures sensed by the temperature sensor 1128 and temperature sensor 1126 can be used to determine heat loss from the heater 1050 to the outlet 1006. As illustrated in
In some variants, Capsulorhexis can be performed to access the lens 112, which can include performing a smaller Capsulorhexis at 2-3 millimeters. In some variants, the Capsulorhexis can be performed off the visual axis of the eye 100, which can include outside an optical zone.
In some variants, as illustrated in
Although the systems and methods have been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the systems and methods extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the thermal systems, devices, and methods disclosed herein. The scope of this disclosure should not be limited by the particular disclosed embodiments described herein.
Methods of using the foregoing system(s) (including device(s), apparatus(es), assembly(ies), structure(s) or the like) are included; the methods of use can include using or assembling any one or more of the features disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure. Methods of manufacturing the foregoing system(s) are included; the methods of manufacture can include providing, making, connecting, assembling, and/or installing any one or more of the features of the system(s) disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, and all operations need not be performed, to achieve the desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
Conditional language, such as “can,” “could,” “might,” or “may” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
Conjunctive language, such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
Some embodiments have been described in connection with the accompanying drawings. Components can be added, removed, and/or rearranged. Orientation references such as, for example, “top” and “bottom” are for ease of ease of discussion and may be rearranged such that top features are proximate the bottom and bottom features are proximate the top. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
In summary, various embodiments and examples of thermal systems, devices, and methods have been disclosed. Although the systems and methods have been disclosed in the context of those embodiments and examples, it will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or other uses of the embodiments, as well as to certain modifications and equivalents thereof. This disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another. Accordingly, the scope of this disclosure should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
This application claims the priority benefit of U.S. Provisional Application No. 63/530,443, filed Aug. 2, 2023, and U.S. Provisional Application No. 63/442,058, filed Jan. 30, 2023, which are hereby incorporated by reference in their entireties. All applications for which a foreign or domestic priority is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
| Number | Date | Country | |
|---|---|---|---|
| 63530443 | Aug 2023 | US | |
| 63442058 | Jan 2023 | US |
