WO2024256937A1 - Automated phacoemulsification - Google Patents
Automated phacoemulsification Download PDFInfo
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- WO2024256937A1 WO2024256937A1 PCT/IB2024/055592 IB2024055592W WO2024256937A1 WO 2024256937 A1 WO2024256937 A1 WO 2024256937A1 IB 2024055592 W IB2024055592 W IB 2024055592W WO 2024256937 A1 WO2024256937 A1 WO 2024256937A1
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- Prior art keywords
- vacuum
- ultrasound power
- power
- aspiration
- threshold
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
- A61F9/00745—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
Definitions
- This invention generally relates to surgical systems used in ocular surgery and more specifically to an automated phacoemulsification system in ocular surgery.
- the surgeon controls various surgical system parameters. These parameters may include at least aspiration, vacuum, and ultrasound power, wherein ultrasound power controls the handpiece tip oscillation.
- these parameters may include at least aspiration, vacuum, and ultrasound power, wherein ultrasound power controls the handpiece tip oscillation.
- the surgeon controls the parameters via a foot pedal.
- the surgeon may move the foot pedal to one of three zones, wherein a first zone may correspond to irrigation, a second zone may correspond to irrigation and aspiration, and a third zone may correspond to irrigation, aspiration, and ultrasound power.
- the specific parameters that are controllable depend on the zone of the foot pedal.
- the level or amount of a parameter in use would correlate to the pitch of the foot pedal treadle in linear or panel mode, depending on what the user (e.g., surgeon) has specified on the phacoemulsification system. How much surgeons modulate the foot pedal, and the amount of aspiration/vacuum/power used varies and depends on surgical techniques, cataract grade, and progress or stage of the cataract procedure. Most surgeons exercise their skills, techniques, and experiences by controlling the foot pedal to navigate through the surgery. There is not a fixed procedure to follow. Each surgeon may have his/her own method to approach the surgery.
- a phacoemulsification system may also minimize the learning curve for new surgeons and enhance their ability to achieve desired results.
- a computer-based automated phacoemulsification method may include determining a vacuum measurement based on a reading from a sensor coupled to an aspiration line; comparing the vacuum measurement to the at least one vacuum threshold; and providing an ultrasound power based on the comparison of the vacuum measurement to the at least one vacuum threshold.
- a surgical system for automated phacoemulsification may include a handpiece, an aspiration line, a sensor, and a surgical console.
- the aspiration line may be connected to the handpiece.
- the sensor is communicatively coupled with the aspiration line.
- the surgical console may be communicatively coupled to the handpiece.
- the surgical console may be configured to provide a predetermined ultrasound power to the handpiece based on a comparison of a measured vacuum level and at least one vacuum threshold. The measured vacuum level may be based on a reading from the sensor.
- FIG. 1 illustrates an exemplary phacoemulsification system in a functional block diagram
- FIG. 2A to 2B are perspective views of an exemplary foot pedal
- FIG. 2C is a side view of an exemplary foot pedal
- FIGS. 3 to 5 are a graphical depiction of the operation of an automated phacoemulsification system
- FIG. 6 is a graphical depiction of adaptive vacuum thresholds of an automated phacoemulsification system
- FIG. 7A is a graphical depiction of a first example of a “power reset” function of the automated phacoemulsification system
- FIG. 7B is a graphical depiction of a second example of the “power reset” function of the automated phacoemulsification system
- FIG. 7C is a graphical depiction of a third example of the “power reset” function of the automated phacoemulsification system
- FIG. 8 illustrates an exemplary graphical user interface (GUI).
- GUI graphical user interface
- FIG. 9 illustrates an exemplary graphical user interface (GUI).
- a foot pedal of phacoemulsification systems may include three foot pedal positions - position 1 (FP1), position 2 (FP2) and position 3 (FP3) that correspond to the three zones described below.
- FP1 which corresponds to the first zone, may provide irrigation.
- FP2 which corresponds to the second zone, may provide aspiration.
- FP3 which corresponds to the third zone, may provide ultrasound/phacoemulsification.
- Each foot pedal position may be additive, so FP2 provides irrigation and aspiration and FP3 provides irrigation, aspiration, and ultrasound/phacoemulsification.
- the automated phacoemulsification system described herein feathering may not be needed because the surgeon may only need to stay in FP3 (the pitch in FP3 is irrelevant) for the algorithm to start and apply power and aspiration based on the vacuum level relative to the algorithm- defined vacuum thresholds.
- the automated phacoemulsification system will compare vacuum levels and determine when to apply power.
- the automated phacoemulsification system may apply a lower level of power when there is a particle around the tip but not necessarily fully occluding it, and higher level of power when the particle is fully blocking and/or occluding the tip. Therefore, the automated phacoemulsification may not need to move between FP2 and FP3 to titrate how much power or vacuum the system needs. This increased efficiency may reduce ultrasound time and the total amount of energy used during surgery which may decrease patient risk during the procedure.
- the user is in automated phacoemulsification mode in FP3 with the foot pedal (see FIG. 2A to 2C) pushed all the way down (i.e., 100% of PF3) and desires a temporary power boost (e.g., 105% power of the max power setpoint).
- a temporary power boost e.g. 105% power of the max power setpoint.
- the user may lift their foot to about 80% or less within FP3 and then quickly press the treadle all the way back down.
- the user may repeat this motion again quickly (i.e., double tap motion).
- This double tap may result in a temporary power boost, which may last between 1 to 5 seconds.
- the power level may return back to its original set point.
- the user may be hovering in automated phacoemulsification mode in FP3 (e.g., 50% of FP3).
- FP3 e.g. 50% of FP3
- the user may quickly press the treadle all the way down in FP3 two times (i.e., double tap motion).
- This double tap may result in a temporary power boost, which may last between 1 to 5 seconds.
- the power level may return back to its original set point.
- the double tap may activate the power boost if the foot pedal quickly passes from 80% of FP3 to 100% of FP3 two times (e.g., within msec).
- a serial communication cable 103 connects GUI host 101 module and surgical console 102 module for the purposes of controlling the surgical console 102 by the GUI host 101.
- GUI host 101 and instrument host 102, as well as any other component of system 100, may be connected wirelessly.
- Surgical console 102 may be considered a computational device in the arrangement shown, but other arrangements are possible.
- An interface communications cable 120 is connected to surgical console 102 module for distributing instrument parameter/sensor data 121, and may include distribution of instrument settings and parameters information, to other systems, subsystems and modules within and external to surgical console 102 module. Although shown connected to the surgical console 102 module, interface communications cable 120 may be connected or realized on any other subsystem (not shown) that could accommodate such an interface device able to distribute the respective data.
- a switch module associated with a foot pedal 104 may transmit control signals relating internal physical and virtual switch position information as input to the surgical console 102 over serial communications cable 105.
- the foot pedal 104 may be connected wirelessly (e.g., Bluetooth, infrared, etc. to the surgical console 102.
- Surgical console 102 may provide a database file system for storing configuration parameter values, programs, and other data saved in a storage device (not shown).
- the database file system may be realized on the GUI host 101 or any other subsystem (not shown) that could accommodate such a file system.
- the phacoemulsification system 100 may include a sensor system.
- the system 100 may include at least one sensor 118 coupled anywhere along the aspiration line 116.
- one or more sensors may be located in the handpiece 110, the console 102, and/or coupled anywhere along the aspiration line 116.
- the system 100 may also include at least one sensor coupled anywhere along the irrigation line 113. Measurements and/or data from the at least one sensor 118 may be communicated to the surgical console 102.
- the surgical console 102 generally comprises at least one processor board.
- Surgical console 102 may include many of the components of a personal computer, such as a data bus, a memory, input and/or output devices (including a touch screen (not shown)), and the like.
- Surgical console 102 will often include both hardware and software, with the software typically comprising machine readable code or programming instructions for implementing one, some, or all of the methods described herein.
- the code may be embodied by a tangible media such as a memory, a magnetic recording media, an optical recording media, or the like.
- the user may press the foot pedal towards the floor to change zones. For example, if the user is in the first zone 210, they can press the foot pedal towards the floor to change to the second zone 220 (similar to how a driver presses the accelerator to increase a vehicles speed).
- the thresholds e.g., amount of force required
- the threshold may be adjusted via a graphical user interface on the surgical console.
- the available travel length of the treadle in each zone of the foot pedal may be increased or decreased and a detent or other indicator (e.g., tactile, or audible) may be placed between zones to indicate movement from one zone to another.
- FIG. 3 is a graph 300 which depicts the operation of an automated phacoemulsification algorithm (automated phacoemulsification) for a phacoemulsification system.
- the system may be the system 100 depicted in FIG. 1 or any other phacoemulsification system known in the art.
- the operation of the system may be performed at least in part via the surgical console’s 102 computer-based software.
- a user such as a surgeon or operator, may select or define specific settings prior to beginning of a procedure (e.g., operation or surgery).
- the settings that may be defined for regular phacoemulsification mode on a phacoemulsification system may include U/S power (%) and different power configurations/modalities (e.g., Pulse, WhiteStar, etc.), aspiration (cc/min), vacuum (mmHg).
- U/S power %
- different power configurations/modalities e.g., Pulse, WhiteStar, etc.
- aspiration cc/min
- vacuum mmHg
- a minimum and maximum setpoint may be specified.
- Each setpoint may depend on the selected mode (i.e., linear or panel). For example, in linear mode, a user may need to define both a minimum and maximum setpoint, but in panel mode, only a maximum setpoint may be needed.
- a user may select the described setpoints as needed for regular phacoemulsification mode in addition to having to select at least one additional user inputted vacuum setpoint/thresholds.
- the user may still define the maximum vacuum setpoint (i.e., V3 in FIG. 3).
- Automated phacoemulsification may allow for at least one additional user inputted vacuum setpoints/thresholds.
- a user may select at least one vacuum threshold V.
- the vacuum thresholds Vi and V2 may be determined by the system where those thresholds would be lesser than the user defined maximum vacuum setpoint V3.
- These vacuum thresholds Vi and V2 and maximum vacuum setpoint V3 essentially define three different vacuum regions that may allow for three different U/S power levels (0-100%) to be applied depending on where the actual vacuum detected in the aspiration line falls within when the user is in FP3.
- a user may select a first vacuum threshold Vi, a second vacuum threshold V2, and a maximum vacuum setpoint V3.
- the second vacuum threshold V2 may be greater than the first vacuum threshold Vi.
- the maximum vacuum setpoint V3 may be greater than the second vacuum threshold V2.
- FIG. 3 shows a system with two vacuum thresholds Vi, V2, more or less vacuum thresholds may be selected by a user, and maximum vacuum setpoint V3 that is user defined. Additionally, the user may select a separate vacuum threshold that triggers when to enable or activate automated phacoemulsification when the foot pedal 200 is in the third zone 230 wherein any vacuum measurement below this vacuum threshold would not activate the automated phacoemulsification even if it is enabled in the GUI settings.
- the phacoemulsification system may allow automated phacoemulsification to be active for as long as the user is in FP3, thus allowing the user to benefit from the power saving aspects of automated phacoemulsification since higher vacuum correlates to full occlusions, during which surgeons would typically use higher amounts of U/S power.
- An automated phacoemulsification algorithm that is a function of this separate vacuum threshold may allow users to manually apply as little power as they desire depending on the FP3 pitch since regular phacoemulsification mode is active; automated phacoemulsification algorithm would kick in only after the separate vacuum threshold is reached.
- the user may select one vacuum threshold and the system may automatically define one or more of the other vacuum thresholds.
- the system would define the first and second vacuum thresholds Vi and V2 based on the maximum vacuum setpoint V3.
- the system may automatically define the second vacuum threshold V2 as 50% of the user selected maximum vacuum setpoint V3 and the first vacuum threshold as 50% of the second vacuum threshold V2.
- the system may automatically define the at least one vacuum threshold
- Vi, V2, V3 based on the vacuum levels during regular mode (i.e., when automated phacoemulsification is not activated). For example, if the maximum vacuum level during regular mode is 400mmHg, the system may automatically define 400mmHg as the maximum vacuum setpoint V3. The system may further automatically define additional vacuum levels Vi, V2 based on a percentage of the maximum vacuum setpoint V3.
- a user may toggle between regular mode and automated phacoemulsification mode via the surgical console’s GUI. If enabled, the automated phacoemulsification would be active until the user decides to disable it with the toggle. After disabling the automated phacoemulsification, the system will return to regular mode operation.
- a user may be able to toggle between regular mode and automated phacoemulsification mode via the foot pedal.
- the foot pedal may include a switch that the surgeon can press to toggle between regular mode and automated phacoemulsification mode.
- a vacuum measurement based on the reading from the at least one sensor 118 coupled with the aspiration line 116 is compared to the vacuum thresholds Vi, V2, V3.
- the vacuum thresholds Vi, V2, V3 may define sections 310, 320, 330, wherein a vacuum measurement less than the first vacuum threshold Vi would fall into a first section 310, a vacuum measurement greater than the first vacuum threshold V 1 and less than the second vacuum threshold V2 would fall into a second section 320, and a vacuum measurement greater than the second vacuum threshold V2 and less than the third or maximum vacuum threshold V3 would fall into a third section 330.
- These sections 310, 320, 330 may generally define different stages of occlusion.
- An occlusion may be defined as varying degrees of blockage of the handpiece tip by lens particles.
- a vacuum measurement that falls in the first section 310 may signify no occlusion.
- a vacuum measurement that falls in the second section 320 may signify a weak (or partial) occlusion.
- a vacuum measurement that falls in the third section 330 may signify a strong (or complete or almost complete) occlusion.
- a user may also select the ultrasound power Pi, P2, P3 applied to the handpiece 110 based on the vacuum measurement and its relationship to the selected thresholds. For example, the user may define a first power Pi for the first section 310, a second power P2 for the second section 320, and a third power P3 for the third section 330.
- the system algorithm may automatically define ultrasound power levels for each stage of occlusion based on the power used during regular mode phacoemulsification. For example, the defined automated phacoemulsification ultrasound powers may be based on a percentage of the regular mode ultrasound power level. Further, the power applied (i.e., Pi) prior to the first vacuum threshold (i.e., Vi) may be zero.
- the at least one sensor 118 sends data to the surgical console 102.
- the sensor data is used to determine a real-time vacuum measurement.
- the vacuum measurement is compared to the predetermined vacuum thresholds Vi, V2, or maximum vacuum setpoint V3. If the vacuum measurement falls within the first section 310 (e.g., the vacuum measurement is equal to or below threshold Vi), the first power Pi is automatically applied to the handpiece 110 via the surgical console 102. If the vacuum measurement falls within the second section 320 (e.g., the vacuum measurement passes threshold Vi, but is equal to or lower than threshold V2), the second power P2 is applied.
- the third power P3 is applied.
- the powers Pi, P2, P3 are applied to the handpiece 110 automatically via the surgical console 102 without the user controlling the power via the pitch of the foot pedal 200 treadle.
- a higher vacuum measurement represents a stronger occlusion.
- a stronger occlusion requires higher power to break up the particles and eliminate the occlusion. Therefore, as shown in FIG. 3, the second power P2 may be greater than the first power Pi and the third power P3 may be greater than the second power P2.
- the user may select more than one ultrasound power level for each section. For example, as shown in FIG. 3, the user may select a minimum third power PTMIX and a maximum third power PSMAX.
- the minimum third power PSMIN and the maximum third power PSMAX may be defined as percentages of the third power P3.
- the minimum third power PSMIN may be defined as 35% of the selected third power P3, while the maximum third power PSMAX may be defined as 100% of the third power P3.
- the third power P3 may either be set to panel mode or linearly increase from the minimum third power PTMIX to the maximum third power PSMAX over a user selected period of time T.
- the period of time T may be inherent in the system algorithm.
- the time T affects the slope of the function and produces different functions for different ramp times.
- Tables 1, 2, and 3 below show examples for ramp times T of 0.5, 1, and 2 seconds respectively when the maximum third power PTMAX is 100% and the third minimum power PTMIX is 35%.
- automated phacoemulsification mode may only utilize one vacuum threshold.
- FIG. 4 is a graph which depicts an operation of an automated phacoemulsification system with only one vacuum threshold.
- the system may be the system 100 depicted in FIG. 1.
- the user may be required to press the treadle into third zone 230 to utilize automated phacoemulsification.
- automated phacoemulsification mode may start in a first section 410.
- the ultrasound power Pi may be a percentage of the max power setpoint.
- Pi may be 30% of the max power setpoint.
- Pi may remain constant throughout the first section 410.
- Pl may be 0% of the max power setpoint.
- the automated phacoemulsification algorithm controls the power delivered to the needle of the handpiece based on the one or more selected parameters (e.g., threshold Vi, maximum vacuum set point, maximum power setpoint, ramp time, etc.)
- the ultrasound power P2 in the second section 420 may a be a higher percentage of the max power setpoint than in the first section 410.
- Pi may be 30% of the max power setpoint while P2 may be 70% of the max power setpoint.
- P2 may also increase until it reaches the max power setpoint.
- at Vi P2 may be 70% of the max power setpoint, but increase to the max power setpoint over a predetermined period of time.
- Pi may be 0 and P2 may start at a certain percentage of the max power setpoint and P2 may increase to the max power over a predetermined period of time. In another example, P2 may increase as the vacuum level increases. In another example, P2 may start at Pi and increase to the max power over a predetermined period of time.
- the user may not be able to set the vacuum threshold Vi. Instead, Vi may depend on the tip size of the needle (e.g., gauge), the irrigation sleeve size, the IOP, aspiration flow, and/or the irrigation flow.
- Vi may depend on the tip size of the needle (e.g., gauge), the irrigation sleeve size, the IOP, aspiration flow, and/or the irrigation flow.
- automated phacoemulsification mode may utilize two vacuum thresholds (e.g., Vi and V2).
- FIG. 5 is a graph which depicts an operation of an automated phacoemulsification algorithm with two vacuum thresholds.
- the system may be the system 100 depicted in FIG. 1.
- the user may be required to move the treadle of the foot pedal into third zone 230 to utilize automated phacoemulsification.
- automated phacoemulsification mode may start in a first section 510 (upon the treadle entering third zone 230).
- the ultrasound power Pi may be a percentage of the max power setpoint.
- Pi may be 30% of the max power setpoint.
- Power Pi may remain constant throughout the first section 510 as shown in the graph or in another example, the ultrasound power Pi may increase linearly in the first section 510.
- Pi may be 0% of the max power setpoint and P2 may start at a certain percentage of the max power setpoint.
- P2 may start at zero and increase linearly to the next vacuum threshold.
- a vacuum threshold Vi When a vacuum threshold Vi is reached or passed, the system moves from first section 510 to a second section 520.
- the ultrasound power P2 in the second section 520 may a be a higher percentage of the max power setpoint than in the first section 510.
- P2 may remain constant throughout the second section 520.
- P2 may increase over a predetermined period of time.
- P2 may increase as the vacuum level increases.
- the ultrasound power P3 in the third section 530 may a be a higher percentage of the max power setpoint than in the first section 510 and section 520.
- P3 may be the max power setpoint.
- P3 may remain constant throughout the third section 530.
- P3 may increase over a predetermined period of time.
- P3 may increase as the vacuum level increases.
- power applied in each of the sections 510, 520, and 530 may be in panel mode (i.e., no power ramping).
- the user may not be able to set the vacuum threshold Vi or V2. Instead, Vi and/or V2 may depend on the needle tip size and/or shape, the sleeve size and/or shape, the IOP, aspiration flow, and/or the irrigation flow.
- the threshold levels discussed above may be based on real-time estimated intraocular pressure (IOP), tip size, and aspiration flow rate.
- IOP intraocular pressure
- Real-time IOP may be calculated by the irrigation sensor, irrigation speed, and sleeve resistance.
- B may be defined as the positive constant B based on tip size.
- Actual pressure difference and flow rate may follow a second-degree polynomial relationship due to fluid turbulence at low flow rates (Navier-Stokes equation).
- the two constants used to define the second-degree polynomial equation in the vacuum threshold calculation algorithm (A and B) may be determined by fitting a polynomial trendline to experimental data gathered by measuring the pressure difference between the aspiration line and the tip at various flow rates at free vacuum and partially occluded situations for threshold 1 and threshold 2, respectively.
- a constant offset was included in the equation to account for pulsation in steady state IOP. This constant offset may be determined experimentally by averaging the peak-to- peak steady flow IOP pulsation in a rigid chamber.
- pressure offset may be subtracted from, and pressure difference equation is added to the real-time estimated IOP.
- a user may be able to select a sensitivity level for the above described automated phacoemulsification threshold levels. For example, a user may be able to select a low, medium, or high sensitivity option. Based on reaching or passing a threshold, the sensitivity level may determine how soon the power will activate when the user is operating in automated phacoemulsification. For example, if the user selects a “high” sensitivity level, the power may activate sooner at a lower vacuum level (i.e., higher aspiration pressure). If the user selects a “low” sensitivity level, the power may activate at a higher vacuum level (i.e., lower aspiration pressure). [0073] FIG.
- FIG. 6 is a graph that illustrates the aspiration flow for a 19Ga tip, 20Ga tip, and 21Ga tip at high, medium, and low sensitivity levels. Specifically, FIG. 6 illustrates the varying or adaptive thresholds levels across different aspiration set points (ml/min) when the IOP is set to 70mmHg for a 19Ga tip, 20Ga tip, and21Ga tip.
- each tip size is also profiled for high, medium, and low sensitivity levels.
- a low sensitivity level may contain a set of higher vacuum levels/thresholds. With a low sensitivity level, the system will activate power when it detects a full occlusion.
- a high sensitivity level may contain a set of lower vacuum levels/thresholds. With a high sensitivity level, the system will activate power if it detects a partial occlusion.
- the user may select segments of the foot pedal 200 treadle to designate linear verses panel mode. For example, the user may designate the 0-50% segment of the foot pedal 200 treadle in the third zone 230 to define linear mode, and the 51-100% segment of the foot pedal 200 treadle in the third zone 230 to define panel mode.
- the user may also select the power modality or configuration prior to surgery.
- the user may select power to be either continuous, pulse (short or long pulses), or supersonics mode.
- the user may also use WhiteStar mode or Variable WhiteStar mode in conjunction with either continuous, pulse, or supersonics mode.
- continuous mode the power is constantly on and applied when the user is in the third zone 230.
- pulse mode the surgeon may specify the number of pulses per second. For example, the surgeon may be able to specify anywhere between 1 to 100 pulses per second. The amount of power applied in each pulse may depend on the max power setpoint.
- the applied power may range from 1-14 pulses per second with a pulse width of 50 milliseconds (ms) (+/- 5ms).
- the applied power may range from 1-6 pulses per second with a pulse width of 50ms (+/- 150ms).
- the applied power allows the phacoemulsification tip a motion greater than lOOKHz.
- modulated pulses of energy are delivered with brief cooling periods applied based on duty cycles expressed as pulse time on/off that is user defined.
- Variable WhiteStar different duty cycles per user selection apply modulated pulses of energy are delivered depending on the FP3 pitch.
- the FP3 zone is divided into four quadrants, and different duty cycles are applied depending on the quadrant.
- a user may select aspiration levels for each section 310, 320, 330 prior to surgery.
- the user may select a maximum aspiration level unique to each section 310, 320, 330 to correlate to occlusion and vacuum levels.
- the system algorithm may automatically define the aspiration levels based on the aspiration applied during regular mode phacoemulsification.
- the system may apply high aspiration levels or an “aspiration boost” for low or weak occlusion levels, including the first and second section 310, 320, and low aspiration levels for strong occlusion levels, including the third section 330 (FIG. 3).
- the aspiration boost may be used to draw particles to the tip of the handpiece 110 when then there is no or weak occlusion.
- the aspiration is provided automatically by the surgical console 102 based on the vacuum measurement and corresponding section 310, 320, 330.
- the aspiration boost may provide 120% of the aspiration max setpoint when the surgeon is operating in the second zone 220 or third zone 230.
- the aspiration boost may provide the 100% of the aspiration max setpoint when the surgeon is operating in third zone 230.
- the aspiration boost may provide 70% of the aspiration max setpoint when the surgeon is operating in the third zone 230.
- the third zone 230 may be split into multiple segments such that the surgeon can specify different power ramping/profiling behavior based on how far the treadle has traveled within the third zone 230 (e.g., FP3).
- the 0-50% segment of FP3 may be defined as linear mode
- the 51-100% segment may be defined as panel mode.
- other power profiling/ramping behavior may also be available for user selection and/or as manufacturer settings where the power would increment accordingly per a defined maximum power setpoint (e.g., set by the user and/or manufacturer) could include linear, panel, exponential, and logarithmic.
- FIG. 7A is a graph 700 which depicts a first example of a “power reset” function.
- the user may elect to enable a “power reset” option.
- the “power reset” function prevents power stagnation at high occlusion and high vacuum levels. For example, a power reset may occur when VI is 125mmHg, V2 is 250mmHG, and the max power setpoint is 500mmHg.
- the power When the power reaches the maximum power setpoint PIMAX for a predetermined period of time, the power will automatically reset to a lower power level.
- the predetermined period of time may be selected by the user or the predetermined period of time may be inherent in the automated phacoemulsification algorithm.
- the time may depend on the occlusion level.
- the “power reset” function aids in breaking up the cataract efficiently as well as allow particle tumbling at the phacoemulsification tip. Alternating between maximum power and resetting to lower powers could also aid in repositioning the particle at the tip of the handpiece 110 and aid in enhanced particle grab and holdability by the handpiece 110, all while remaining cognizant of overall power usage.
- the power may reset to the third minimum power PSMIN after reaching the maximum power PIMAX for the predetermined period of time. After resetting to the third minimum power PSMIN, the power may incrementally increase back up to the maximum power PIMAX. The power may continuously cycle in this way during automated phacoemulsification.
- sections 710, 720, and 730 define the different vacuum levels detected in the aspiration line based on different levels of occlusion that may be encountered during a phacoemulsification surgery where a user may select at least one vacuum threshold V.
- the vacuum thresholds Vi and V2 may be determined by the system where those thresholds would be lesser than the user defined maximum vacuum setpoint V3.
- different power levels Pi, P2, or P3 would be applied respectively in either panel mode or linear mode.
- FIGs. 7B and 7C illustrate graphs which depict alternative examples of the “power reset” function. These examples have the same purpose and function as the “power reset” shown in FIG. 7A. However, as shown in FIG. 7B, the power may reset to the second power P2. As shown in FIG. 7C, the power may reset to the first power Pi. The power level may increase (e.g., Pi to P2) based on the real-time vacuum level.
- a user is able to select from different “power reset” options prior to surgery. For example, the user may select “off,” wherein the “power reset” is disabled and no reset will occur; “low,” wherein the “power reset” will reset to the third minimum power PIMIX; “medium,” wherein the “power reset” will reset to the second power P2; or “high,” wherein the “power reset” will reset to the first power Pi.
- the different “power reset” levels provide surgeons with different options as to how much or how little the surgeon would like to reset the power while at high occlusion and vacuum levels when using automated phacoemulsification.
- FIG. 8 shows an example graphical user interface (GUI) 800 when automated phacoemulsification is enabled.
- GUI graphical user interface
- the GUI may display various parameters, including aspiration levels 802, vacuum levels 804, power levels 806, and IOP 808.
- Automated phacoemulsification parameters may be inputted or selected by the user via the GUI.
- the user may be presented with suggested prefilled parameters. Alternatively, the user may be presented with parameters previously saved by the user.
- the parameter may include, but is not limited to, max power setpoint, max aspiration setpoint, max vacuum setpoint, vacuum threshold 2, and/or power ramp time.
- the parameters inputted via the GUI and stored by the surgical console 102 are applied automictically when the automated phacoemulsification algorithm is activated during the procedure or surgery.
- the max power setpoint may be the maximum power percentage (from 0- 100%) output through the handpiece when operating in the third zone 230.
- the max aspiration setpoint may be the maximum aspiration flow, from 0-80 cc/minute output through the handpiece.
- the max vacuum setpoint may be the maximum, from 0-600mmHG, pull in the aspiration line to pull and remove lens particles from the eye.
- the vacuum threshold 2 described in FIG. 3 above may be the threshold that dictates the vacuum level that signifies a “full occlusion,” which signals the system to apply more power starting from 35% of the max power setpoint to the max power setpoint.
- Power ramp time may specify how fast the power will ramp up section 330 (from 35% of the max power setpoint to the max power setpoint). The ramp time may have three options - 0.5 seconds, 1 second, and 2 seconds.
- FIG. 9 shows an example GUI 900 for the automated phacoemulsification sensitivity settings.
- the user can select low sensitivity 902, medium sensitivity 904, or high sensitivity 906. Further, the user may adjust settings related to fluidics 910, vacuum 912, IOP 914, and Power 916.
- FIG. 10 is a flow chart of a computer-based automated phacoemulsification method 1000.
- the components and functions involved in the computer-based automated phacoemulsification method include the same details and examples described above.
- the method 1000 is used to automatically deliver ultrasound power and/or aspiration to a handpiece during a phacoemulsification procedure or surgery based on pre-selected and/or pre-defined parameters and a vacuum measurement based on a sensor coupled with the aspiration line or irrigation line.
- step 1010 at least one vacuum threshold is received.
- the at least one vacuum threshold may be selected by a user via the GUI.
- at least one of the vacuum thresholds may be defined by the system algorithm.
- the user may define a maximum vacuum threshold, while the algorithm defines at least one other vacuum threshold based on the maximum vacuum threshold.
- the at least one vacuum threshold designates different occlusion levels.
- a vacuum measurement is determined based on a reading from the sensor coupled with the aspiration line of the phacoemulsification system.
- the vacuum measurement is determined during the phacoemulsification procedure in real-time.
- the AVS module 1100 may include an irrigation-in port 1102, irrigation-out port 1004, aspiration-in port 1106, and aspiration-out port 1108.
- the irrigation fluid may flow from the irrigation fluid source 112 into the AVS 1100 through the irrigation-in port 1102 and out of the AVS 1100 through the irrigation-out port 1104.
- the aspiration fluid may flow from the eye through handpiece 110 into the AVS through the aspiration-in port 1106 and out of the AVS 1100 through the aspiration- out port 1108.
- the AVS 1000 may further include a valve 1110 (e.g., a solenoid valve), sensor 1112 (e.g., pressure or flow), and other electronics 1114.
- the AVS may have one or more sensors coupled with the irrigation side.
- the AVS module 1100 may be used to detect intraocular pressure (IOP), flow (irrigation & aspiration), and reduce post occlusion surge.
- the valve 1110 can be activated to close the aspiration line when the sensor 1112 senses a sudden drop in vacuum at a certain rate. When the valve is closed, the power that is delivered below the first threshold (as described in FIGs. 3, 4, and/or 5), may be zero or a minimal power level.
- an ultrasound power is provided to the handpiece of the phacoemulsification system based on the comparison of the vacuum measurement to the at least one vacuum threshold.
- the amount or level of ultrasound is determined based on whether the vacuum measurement is greater than or less than the at least one vacuum threshold. If the vacuum measurement is equal to the threshold, the ultrasound power may the power level set prior to reaching the threshold. For example, in FIG. 4, if the vacuum measurement is equal to Vi, the ultrasound power may be Pi.
- the amount or level is set by the user or system algorithm prior to surgery, but may also be set or adjusted during surgery.
- the profile and mode of the ultrasound power may also be selected by the user or system algorithm and automatically applied during the procedure.
- the system may also apply other parameters, such as aspiration, based on the comparison of the vacuum measurement to the at least one vacuum threshold. The aspiration may be selected by a user or system algorithm prior to the procedure.
- Automated phacoemulsification may also be used with surgical systems that utilize one or more pumps, e.g., a peristaltic pump, progressive cavity pump and/or venturi pump.
- a peristaltic pump when the surgeon is in FP3, the venturi pump may be leveraged as a “vacuum boost” when the vacuum level is in section 1 and section 2. This may help increase followability and draw particles to the phacoemulsification tip during surgery. After the particles are purchased and create a high state of occlusion, the vacuum level will reach section 3, where the venturi pump will no longer be activated. The peristaltic pump may then be used for maintaining vacuum until the vacuum level reduces after the particle at the tip is emulsified and aspirated.
- a computer-based surgical support method comprising: receiving at least one vacuum threshold; determining a vacuum measurement based on a reading from a sensor (118) coupled with an aspiration line (116); comparing the vacuum measurement to the at least one vacuum threshold; and providing an ultrasound power based on the comparison of the vacuum measurement to the at least one vacuum threshold.
- Example 3 The method of example 1, wherein the at least one vacuum threshold is a first vacuum threshold, and further comprising: receiving a second vacuum threshold; comparing the vacuum measurement to the second vacuum threshold; and providing a second ultrasound power based on the comparison of the vacuum measurement to the second vacuum threshold wherein providing the second ultrasound power based on the comparison of the vacuum measurement to the second vacuum threshold includes providing the second ultrasound power if the vacuum measurement is greater than the second vacuum threshold.
- Example 4 The method of any of examples 1 to 2, wherein a user inputs the at least one vacuum threshold.
- the at least one vacuum threshold is based on at least one of a tip size of the needle, an irrigation sleeve size, an intraocular pressure, aspiration flow, and an irrigation flow.
- providing the ultrasound power based on the comparison of the vacuum measurement to the at least one vacuum threshold includes providing a first ultrasound power if the vacuum measurement is less than the at least one vacuum threshold and providing a second ultrasound power if the vacuum measurement is greater than the at least one vacuum threshold.
- the second ultrasound power includes an initial ultrasound power and a maximum ultrasound power
- the second ultrasound power linearly increases from the initial ultrasound power to the maximum ultrasound power over a predetermined period of time.
- Example 11 The method of example 9, wherein the second ultrasound power decreases to a lower power when the second ultrasound power is at the maximum ultrasound power for a predetermined period of time.
- Example 12 The method of example 7, wherein the second ultrasound power includes an initial ultrasound power and a maximum ultrasound power, and the second ultrasound power linearly increases from the initial ultrasound power to the maximum ultrasound power as the vacuum measurement increases.
- Example 13 The method of example 7, wherein the second ultrasound power includes an initial ultrasound power and a maximum ultrasound power, and the second ultrasound power linearly increases from the initial ultrasound power to the maximum ultrasound power is based on a predetermined period of time.
- providing the aspiration boost based on the comparison of the vacuum measurement to the vacuum threshold includes providing a first aspiration boost if the vacuum measurement is less than the at least one vacuum threshold and providing a second aspiration boost if the vacuum measurement is greater than the at least one vacuum threshold.
- Example 20 The method of any of the example 1 to 18, wherein the ultrasound power is a percentage of a max power setpoint.
- a surgical system (100) comprising: a handpiece (110); an aspiration line (116) coupled with the handpiece; a sensor (118, 112) communicatively coupled with the aspiration line (116); and a surgical console (102) communicatively coupled to with the handpiece (110), the surgical console (102) configured to provide a predetermined ultrasound power to the handpiece (110) based on a comparison of a measured vacuum level and at least one vacuum threshold, the measured vacuum level is based on a reading from the sensor (118, 112).
- the vacuum threshold is based on at least one of a tip size of the needle, an irrigation sleeve size, an intraocular pressure, aspiration flow, and an irrigation flow.
- a first ultrasound power is provided if the measured vacuum level is less than the at least one vacuum threshold and a second ultrasound power is provided if the measured vacuum level is greater than the at least one vacuum threshold.
- Example 28 The surgical system of example 26, wherein the second ultrasound power is greater than the first ultrasound power.
- the second ultrasound power includes an initial ultrasound power and a maximum ultrasound power
- the second ultrasound power linearly increases from the initial ultrasound power to the maximum ultrasound power as the vacuum measurement increases.
- the second ultrasound power includes an initial ultrasound power and a maximum ultrasound power
- the second ultrasound power linearly increases from the initial ultrasound power to the maximum ultrasound power as the vacuum measurement increases.
- the surgical console includes a graphical user interface (800, 900) configured to receive a user input.
- a graphical user interface 800, 900
- Example 35 The surgical system of any of the examples 20 to 33, wherein the surgical console is further configured to provide an aspiration boost based on the comparison of the measured vacuum level to the at least one vacuum threshold.
- a first aspiration boost is provided if the measured vacuum level is less than the at least one vacuum threshold and a second aspiration boost is provided if the measured vacuum level is greater than the at least one vacuum threshold.
- a first aspiration boost is provided if the measured vacuum level is less than the at least one vacuum threshold and a second aspiration boost is provided if the measured vacuum level is greater than the at least one vacuum threshold.
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Abstract
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP24735704.9A EP4727502A1 (en) | 2023-06-13 | 2024-06-07 | Automated phacoemulsification |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18/334,305 US20230320897A1 (en) | 2019-08-16 | 2023-06-13 | Automated phacoemulsification |
| US18/334,305 | 2023-06-13 |
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| WO2024256937A1 true WO2024256937A1 (en) | 2024-12-19 |
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| PCT/IB2024/055592 Ceased WO2024256937A1 (en) | 2023-06-13 | 2024-06-07 | Automated phacoemulsification |
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| EP (1) | EP4727502A1 (en) |
| WO (1) | WO2024256937A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140257172A1 (en) * | 2013-03-07 | 2014-09-11 | Alcon Research, Ltd. | Active acoustic streaming in hand piece for occlusion surge mitigation |
| US20140323953A1 (en) * | 2013-04-26 | 2014-10-30 | Alcon Research, Ltd. | Partial Venting System for Occlusion Surge Mitigation |
| US20190099526A1 (en) * | 2017-10-04 | 2019-04-04 | Abbott Medical Optics Inc. | Advanced Occlusion Management Methods for a Phacoemulsification System |
| US20210045918A1 (en) * | 2007-05-24 | 2021-02-18 | Johnson & Johnson Surgical Vision, Inc. | System and method for controlling a transverse phacoemulsification system using sensed data |
-
2024
- 2024-06-07 EP EP24735704.9A patent/EP4727502A1/en active Pending
- 2024-06-07 WO PCT/IB2024/055592 patent/WO2024256937A1/en not_active Ceased
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20210045918A1 (en) * | 2007-05-24 | 2021-02-18 | Johnson & Johnson Surgical Vision, Inc. | System and method for controlling a transverse phacoemulsification system using sensed data |
| US20140257172A1 (en) * | 2013-03-07 | 2014-09-11 | Alcon Research, Ltd. | Active acoustic streaming in hand piece for occlusion surge mitigation |
| US20140323953A1 (en) * | 2013-04-26 | 2014-10-30 | Alcon Research, Ltd. | Partial Venting System for Occlusion Surge Mitigation |
| US20190099526A1 (en) * | 2017-10-04 | 2019-04-04 | Abbott Medical Optics Inc. | Advanced Occlusion Management Methods for a Phacoemulsification System |
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| EP4727502A1 (en) | 2026-04-22 |
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