Patent Application
20230255822
The present disclosure relates generally to phacoemulsification systems and probes, and particularly to controlling intraocular pressure in phacoemulsification procedures.
A cataract is a clouding and hardening of the eye’s natural lens, a structure which is positioned behind the cornea, iris and pupil. The lens is mostly made up of water and protein and as people age these proteins change and may begin to clump together obscuring portions of the lens. To correct this, a physician may recommend phacoemulsification cataract surgery. In the procedure, the surgeon makes a small incision in the sclera or cornea of the eye. Then a portion of the anterior surface of the lens capsule is removed to gain access to the cataract. The surgeon then uses a phacoemulsification probe, which has an ultrasonic handpiece with a needle. The tip of the needle vibrates at ultrasonic frequency to break and emulsify the cataract while a pump aspirates particles and fluid from the eye through the tip. Aspirated fluids are replaced with irrigation of a balanced salt solution to maintain constant intraocular pressure (IOP) in the anterior chamber of the eye. The cataract removal must be carried out while retaining constant IOP in order to prevent permanent damage to the eye.
After removing the cataract with phacoemulsification, the softer outer lens cortex is removed with suction. An intraocular lens (IOL) is then introduced into the empty lens capsule restoring the patient’s vision.
The present disclosure will be more fully understood from the following detailed description of the examples thereof, taken together with the drawings in which:
During phacoemulsification of an eye lens, emulsified lens particles are aspirated from the eye, while applying irrigation fluid to the eye. It is important to match between the amount of irrigation fluid applied to the eye and emulsified lens particles and irrigation fluid aspirated from the eye, so as to maintain a constant intraocular pressure (IOP) in the eye.
Examples of the present disclosure that are described hereinafter provide techniques for controlling constant IOP during a cataract surgery, using adaptive flow rates of the irrigation and aspiration fluids.
In some examples, a phacoemulsification system comprises an ultrasonic handpiece having a needle mounted thereon. The tip of the needle is configured to vibrate at an ultrasonic frequency to break the cataract into particles, which are emulsified in fluids applied to the eye. The system comprises two progressive cavity pumps (PCPs) integrated together in a pumping assembly, which is referred to herein as a pump having one or two electric motors, and is described in detail in
In some examples, the pump is configured to aspirate the emulsified particles and fluid, also referred to herein as aspiration fluid(s), from the treated eye while applying irrigation fluid to the eye, so as to maintain constant IOP in the eye. The irrigation and aspiration fluids flow between the pump and the eye through the tip of the needle and sleeve.
In some examples, the pump comprises a cassette having irrigation and aspiration chambers configured to flow the irrigation and aspiration fluids therethrough, respectively. In principle, the irrigation and aspiration chambers of the cassette are designed to have a similar volume. In some cases, however, the volume of the chambers differs from one another (e.g., by up to 5%) due to variations in the production process of the cassette, also referred to herein as manufacturing tolerances. In such cases, the flow rate of the irrigation and/or aspiration fluids must be adjusted to compensate for the difference between the volume of the irrigation and aspiration chambers. Note that the flow rate adjustments are essential for matching the volume of irrigation and aspiration fluids exchanged between the pump and the eye in question.
A possible solution to the problem of unequal volume of the cassette chambers is to measure the pressure in both irrigation and aspiration lines, and responsively, to adjust the flow rates of the irrigation and aspiration fluids to obtain a target constant pressure in both irrigation and aspiration lines. In the present example the flow rate is altered by adjusting the operating speed (e.g., revolutions per minute) of the motor(s) of the pump. This solution, however, is prone to aggressive operation of the system in response to various situations that may occur during the cataract surgery. For example, a sudden drop in vacuum may be caused in response to an occluding particle at the tip of needle being emulsified and aspirated.
In some examples, the phacoemulsification system may be operated using constant flows (rather than constant pressure) of the irrigation and aspiration fluids, after performing a calibration procedure described herein.
In some examples, the calibration procedure begins with coupling, to a distal end of a phacoemulsification handpiece, a needle and sleeve having a given diameter, and fitting an expandable calibration chamber on a tip of the needle and sleeve. The calibration chamber is configured to expand (e.g., inflate) and collapse (e.g., deflate) based on the amount of fluid residing therein. More specifically, when the inflowing volume of fluid is larger than the outflowing volume, the calibration chamber is configured to inflate, and when the outflowing volume is larger than the inflowing volume of fluid, the calibration chamber is configured to deflate. Subsequently, a user operates the pump associated with the irrigation line coupled with the phacoemulsification handpiece at a target constant flow rate and a processor of the system records the irrigation flow rate sensed by a suitable sensing device during a predefined time interval. At the same time, the user operates the pump associated with the aspiration line coupled with the phacoemulsification handpiece to obtain a constant target pressure of the fluid residing in the calibration chamber. Moreover, flow rate and pressure of the aspiration fluid are measured in the aspiration line, and the readings thereof are recorded by the processor during the same predefined time interval.
In some examples, the processor is configured to compute integrals of the irrigation and aspiration flow rates recorded during the predefined time interval, and to calculate a ratio of flow rates required to obtain constant pressure in the calibration chamber. Note that the pressure in the calibration chamber is indicative of the IOP in the eye during a cataract surgery.
In some examples, the user may repeat the calibration process described above with a different type of a needle and sleeve, and/or a different cassette and/or using different parts and operational conditions of irrigation and aspiration. Moreover, the processor is configured to produce or use a lookup table (LUT) comprising the calculated flow rate ratio for each of the aforementioned parts and/or operational condition.
In some examples, in setting up the cataract surgery the user selects a needle, a cassette of the pump and other parts, and sets the operational conditions of the surgery. In such examples, the processor applies a suitable flow rate ratio of the LUT, so as to set respective constant flow rates of the irrigation and aspiration fluids for obtaining constant intraocular pressure. Subsequently, the user begins the cataract surgical procedure, and based on the ratios in the LUT, the processor controls the pump to execute the respective constant flow rates of the irrigation and aspiration fluids.
The disclosed technique improves the safety of phacoemulsification procedures, for example, by compensating for manufacturing tolerances in the irrigation and aspiration chambers of the cassette of the respective progressive cavity pumps.
In some examples, phacoemulsification system 10 comprises a phacoemulsification probe 12, also referred to herein as a phacoemulsification handpiece or as a probe 12, for brevity, shown in an inset 25. Phacoemulsification probe 12 comprises a needle 16 and a coaxial irrigation sleeve 56 that at least partially surrounds needle 16 and creates a fluid pathway between the external wall of the needle and the internal wall of irrigation sleeve 56. Note that needle 16 is hollow, has a predefined diameter at the tip, and is configured to function as an aspiration channel. Moreover, irrigation sleeve may have one or more side ports at or near the distal end to allow irrigation fluid to flow towards the distal end of the handpiece through the fluid pathway and out of the port(s).
In some examples, needle 16 is configured for insertion into a lens capsule 18 of an eye 20 of a patient 19 by a physician 15 to remove a cataract. While needle 16 (and irrigation sleeve 56) are shown in inset 25 as a straight object, any suitable needle may be used with phacoemulsification probe 12, for example, a curved or bent tip needle commercially available from Johnson & Johnson Surgical Vision, Inc., Irvine, CA, USA.
Reference is now made to the general view of
Reference is now made back to inset 25. In an example, aspiration fluid(s), such as eye fluid and waste matter (e.g., emulsified parts of the cataract), are aspirated from eye 20 by pump 44. The aspiration fluids are aspirated through hollow needle 16, via an aspiration channel 46a of probe 12 and an aspiration (tubing) line 46, to the collection receptacle (also referred to herein as a waste reservoir) (not shown) located within or coupled externally to pumping sub-system 26.
Reference is now made to inset 60. In some examples, cassette 55 comprises two progressive cavity pumps (PCPs) configured to be inserted into and removed from console 28, and to actuate each of the irrigation and aspiration flows. Each of the PCPs comprises a stator and a rotor, which couple with a motor of pump 44 and together are configured to move the fluids into and out of the eye. In the present example, cassette 55 comprises an aspiration chamber 66, which is made from a hollow tube. The volume of aspiration chamber 66 is defined by: (i) the inner diameter of the hollow tube, and (ii) the distance between a rotatable screw 86 and an opening 76, which is configured to couple with aspiration line 46. Similarly, cassette 55 comprises an irrigation chamber 63, which is also made from a hollow tube. The volume of irrigation chamber 63 is defined by: (i) the inner diameter of the hollow tube, and (ii) the distance between a rotatable screw 83 and an opening 73, which is configured to couple with irrigation line 43. In the present example, rotatable screw 83 is configured to be rotatably actuated by the respective motor of the PCP for flowing the irrigation fluid, and rotatable screw 86 is configured to be rotatably actuated by the respective motor of the PCP for flowing the aspiration fluid.
In an example, cassette 55 comprises a bracket 65, which is configured to serve as a handle for inserting and removing cassette 55 into and out of console 28, respectively. In an inserted position, chambers 63 and 66 and rotatable screws 83 and 86 are being inserted into console 28, whereas bracket 65 and openings 73 and 76 are positioned on an external panel of console 28 and are visible to a user of system 10. In this configuration, the user of system 10 may connect or disconnect between irrigation line 43 and opening 73, and between aspiration line 46 and openings 76.
In some cases, the volume of irrigation chamber 63 and aspiration chamber 66 may differ from one another, typically due to process variations that may occur during the production of cassette 55. The volume difference may be caused, for example, by uneven inner diameter of the respective hollow tubes, and/or by uneven distance between the respective opening and the rotatable screws of the respective chambers. Note that an equal flow rate of the irrigation and aspiration fluids, together with a difference in the volume of chambers 63 and 66, typically results in a different volume of irrigation and aspiration fluids flowing into and out of eye 20, respectively. Such differences typically alter the IOP within eye 20, and may cause a damage to the eye. A method for maintaining an equal volume of irrigation and aspiration fluids flowing into and out of eye 20, respectively, is described in detail in
In another example, the pumping sub-system 24 may be coupled or replaced with a gravity fed irrigation source such as a balanced salt solution bottle/bag.
In some examples, phacoemulsification probe 12 may comprise additional elements (not shown), such as a piezoelectric crystal coupled to a horn to drive vibration of needle 16. The piezoelectric crystal is configured to vibrate needle 16 in a resonant vibration mode. The vibration of needle 16 is used to break a cataract of eye 20 into small pieces during a phacoemulsification procedure. Console 28 comprises a piezoelectric drive module 30, coupled with the piezoelectric crystal, using electrical wiring running in a cable 33. Drive module 30 is controlled by a processor 38 and conveys processor-controlled driving signals via cable 33, for example, to maintain needle 16 at maximal vibration amplitude. The drive module may be implemented in hardware or software, for example, in a proportional-integral-derivative (PID) control architecture.
In some embodiments, processor 38 may receive user-based commands via a user interface 40, which may comprise setting a vibration mode and/or frequency of the piezoelectric crystal, and setting or adjusting an irrigation and/or aspiration flow rate obtained by controlling pump 44. In an example, user interface 40 and display 36 may be combined as a single touch screen graphical user interface. In an example, physician 15 may use a foot pedal (not shown) as a means of control. Additionally, or alternatively, processor 38 may receive the user-based commands from controls located in a handle 21 of probe 12.
In an example, some or all of the functions of processor 38 may be combined in a single physical component or, alternatively, implemented using multiple physical components. These physical components may comprise hard-wired or programmable devices, or a combination of the two. In some examples, at least some of the functions of processor 38 may be carried out using suitable software stored in a memory 35 implemented within console 28. This software may be downloaded to a device in an electronic form, over a network, for example. Alternatively, or additionally, the software may be stored in tangible, non-transitory computer-readable storage media, such as optical, magnetic, or electronic memory.
System 10 of
In some examples, calibration chamber 72 resembles eye 20, and is used in a calibration procedure described in
In some examples, one or more sensors 74, such as pressure and/or flow sensors, are located within calibration chamber 72 for sensing the pressure and/or flow rate of the fluids. Additionally, or alternatively, sensors 74 may be located at one or more suitable positions within phacoemulsification probe 12, anywhere along irrigation line 43 and aspiration line 46 shown in
The method comprises a calibration procedure followed by a cataract surgical procedure. The calibration procedure is using the Bernoulli principle that correlates between the pressure and the flow rate of a fluid in a pumping system. More specifically, an increase in the speed of a fluid occurs simultaneously with a decrease in the static pressure of the fluid. The calibration procedure begins at a calibration chamber fitting step 100 with user of system 10 (e.g., physician 15 or a technician) receiving phacoemulsification probe 12 with a selected needle 16 having a tip with a predefined shape and diameter and a sleeve 56, as described in
In some examples, the inflation and deflation of calibration chamber 72 (as described in
At an irrigation and aspiration step 102, processor 38 controls pump 44 to pump fluid into chamber 63, via irrigation line 43, at a constant target flow rate. Moreover, processor 38 records the irrigation flow rate reading sensed, during a predefined time interval (e.g., between about 10 seconds and 180 seconds), by the flow sensors described in step 100 above. While flowing the fluids through irrigation line 43, processor 38 controls pump 44 to pump fluid into aspiration chamber 66 via needle 16 and aspiration line 46, so as to obtain constant pressure in calibration chamber 72. Moreover, processor 38 receives from the sensors signals indicative of the measured pressure level in aspiration line 46, and records, during the same predefined time interval, the flow rate of the fluid flowing in aspiration line 46 and sensed by the flow sensor described in
In alternative examples, step 102 may be carried out the other way around, i.e., flowing the aspiration fluid at a constant target flow rate, and controlling pump 44 to pump fluid via irrigation line 43, so as to obtain constant pressure in calibration chamber 72. In such examples, processor 38 receives from the sensors signals indicative of the measured pressure level in irrigation line 43 and/or in calibration chamber 72, and records, during the same predefined time interval, the flow rate of the fluid flowing in irrigation line 43 and sensed by the aforementioned flow sensors.
At a computation step 104, processor 38 is configured to compute integrals of the irrigation and aspiration flow rates readings recorded during the predefined time interval. Based on the computed integrals, processor 38 is configured to calculate a ratio between the irrigation and aspiration flow rates, which are suitable to obtain a constant pressure in calibration chamber 72. Note that the constant pressure in calibration chamber 72 is indicative of the pressure measured in irrigation line 43 and aspiration line 46. In other examples, pressure sensors may be positioned at the irrigation line 43 and aspiration line 46, and processor 38 may receive signals indicative of the sensed pressure.
In an example, in case the volume of aspiration chamber 66 is larger than that of irrigation chamber 63, e.g., by about 3%, based on the volume difference and the measured flow rate of the fluid in irrigation line 43, processor 38 is configured to calculate a ratio of about 1.03 between the aspiration and irrigation flow rates. In this example, for a measured irrigation flow rate of about 30 cc per minute, processor 38 is configured to set the target aspiration flow to a level of about 30.9, so as to compensate for the difference in the volumes, and to maintain the target pressure in the calibration chamber that resembles eye 20.
At a decision step 106, which is an optional step of the calibration procedure, the user decides whether he or she wants to select another cassette 55 or other operational conditions of system 10. For example, in case the user selects another cassette 55 (that may have different volumes of the irrigation and aspiration chambers), the method loops back to step 100 for calculating the flow rate ratio, as described in step 104 above. Note that in case the user has already selected the specific cassette and operational conditions that have already been used for calibrating system 10, then system 10 is ready to be used in the cataract surgical procedure.
In case the user does not want to select another cassette (instead of cassette 55) and/or other operational conditions, the method proceeds to a flow rate ratio storge step 108 that terminates the calibration procedure. In step 108, processor 38 stores one or more flow rate ratio(s) that define the irrigation/aspiration flow rate ratio for the respective combinations of a suitable type of cassette 55 and operational conditions. In alternative examples, processor 38 is configured to store one or more flow rate ratio(s) in a lookup table (LUT).
In some examples, after concluding the calibration procedure, system 10 is ready to carry out the cataract surgical procedure. In some examples, the surgical procedure may be carried out immediately after concluding the calibration procedure. In such embodiments, physician 15 removes calibration chamber 72 from phacoemulsification probe 12 and uses cassette 55 and the selected operational conditions of system 10 to carry out the cataract surgical procedure.
In other examples, the stored ratios calculated during the calibration procedure may be used in several cataract surgical procedures that may be carried out at any suitable time, when the same cassette 55 is being used for multiple procedures. Note that this combination of the predefined operational conditions and cassette 55 have been used together at the same time during the calibration procedure. Subsequently, physician 15 and/or processor 38 select (from among the stored flow rate ratios or LUT described in step 108 above) a suitable flow rate ratio to set flow rates of the irrigation and aspiration fluids. Note that the flow rates must be suitable under selected operational conditions of phacoemulsification probe 12, so as to obtain a predefined level of constant intraocular pressure in eye 20. After selecting the surgical tools (e.g., probe 12 and cassette 55), the operational conditions, the flow rate, and the flow rate ratio, physician 15 performs the phacoemulsification procedure as shown and described in
The example flow chart shown in
Although the examples described herein mainly address phacoemulsification procedures. The methods and systems described herein can also be used in other applications.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows a physical dimension, such as a time interval, a physical part or collection of components, or a numerical value, such as a percentage or a ratio, to function for its intended purpose as described herein.
A phacoemulsification system (10), including:
The phacoemulsification system according to example 1, wherein the first volume is different from the second volume, and wherein the processor is configured to calculate the second flow rate to compensate for the difference between the first and second volumes.
The phacoemulsification system according to example 2, wherein in a calibration step, the processor is configured to produce, for a given set of conditions, a dataset including: (i) a preset value of the first flow rate, and (ii) a calculated value of the second flow rate.
The phacoemulsification system according to example 3, wherein the given set of conditions includes: (i) the first and second volumes, and (ii) operational conditions of the phacoemulsification system.
The phacoemulsification system according to examples 1 through 3, wherein the first fluid includes an irrigation fluid, which is applied to the eye at the first flow rate, and the second fluid includes an aspiration fluid, which is aspired from the eye at the second flow rate.
The phacoemulsification system according to examples 1 through 3, wherein the first fluid includes an aspiration fluid, which is aspired from the eye at the first flow rate, and the second fluid includes an irrigation fluid, which is applied to the eye at the second flow rate.
The phacoemulsification system according to examples 1 through 3, wherein the pump includes first and second progressive cavity pumps (PCPs) integrated together.
The phacoemulsification system according to example 7, wherein the first PCP includes the first chamber and a first electric motor, which is configured to flow the first fluid, and the second PCP includes the second chamber and a second electric motor, which is configured to flow the second fluid.
The phacoemulsification system according to examples 1 through 8, further including one or more sensors, which are configured to sense at least one of: (i) the first flow rate, (ii) the second flow rate, (iii) a first pressure of the first fluid, and (iv) a second pressure of the second fluid.
A method, including:
The method according to example 10, wherein the first volume is different from the second volume, and wherein calculating the second flow rate is carried out to compensate for the difference between the first and second volumes.
The method according to example 11, and including producing, for a given set of conditions, a dataset including: (i) a preset value of the first flow rate, and (ii) a calculated value of the second flow rate.
The method according to example 12, wherein the given set of conditions includes: (i) the first and second volumes, and (ii) operational conditions of the phacoemulsification system.
The method according to examples 10 through 13, wherein the first fluid includes an irrigation fluid, which is applied to the eye at the first flow rate, and the second fluid includes an aspiration fluid, which is aspired from the eye at the second flow rate.
The method according to examples 10 through 13, wherein the first fluid includes an aspiration fluid, which is aspired from the eye at the first flow rate, and the second fluid includes an irrigation fluid, which is applied to the eye at the second flow rate.
A calibration method, including:
The method according to example 16, wherein the pump comprises a cassette that includes: (i) a first chamber having a first volume for flowing the first fluid, and (ii) a second chamber having a second volume for flowing the second fluid, and wherein when the first and second volumes differ from one another, the readings of the second flow rate differ from the readings of the first flow rate.
The method according to example 17, wherein the cassette has a first inner volume for flowing at least one of the first fluid and the second fluid, further comprising: (i) replacing the cassette with an additional cassette having a second inner volume, for flowing at least one of the first fluid and the second fluid, which is different from the first inner volume, (ii) activating the additional cassette to enable the first flow rate and the second flow rate, (iii) setting the target value and recording the readings, (iv) calculating an additional ratio between the readings of the first flow rate and the readings of the second flow rate, and (v) storing the ratio and the additional ratio in a lookup table.
The method according to example 16, wherein calculating the ratio includes computing, over the predefined time interval, (i) a first integral on the readings of the first flow rate, and (ii) a second integral on the readings of the second flow rate, and calculating the ratio between the first integral and the second integral.
The method according to example 16, wherein the calibration chamber resembles an eye of a patient intended to undergo a phacoemulsification procedure using the phacoemulsification probe.
The method according to example 20, wherein the first fluid includes an irrigation fluid, which is intended to be applied to the eye at the first flow rate, and the second fluid includes an aspiration fluid, which is intended to be aspired from the eye at the second flow rate.
The method according to example 20, wherein the first fluid includes an aspiration fluid, which is intended to be aspired from the eye at the first flow rate, and the second fluid includes an irrigation fluid, which is intended to be applied to the eye at the second flow rate.
The method according to examples 16 through 22, further including storing the calculated ratio for use in a phacoemulsification procedure using the phacoemulsification probe.
The method according to examples 17 through 21, wherein the cassette includes a first inner volume for flowing at least one of the first fluid and the second fluid, further including: (i) replacing the cassette with an additional cassette having a second inner volume, for flowing at least one of the first fluid and the second fluid, which is different from the first inner volume, (ii) activating the additional cassette to enable the first flow rate and the second flow rate, (iii) setting the target value and recording the readings, (iv) calculating an additional ratio between the readings of the first flow rate and the readings of the second flow rate, and (v) storing the ratio and the additional ratio in a lookup table.
The method according to example 16, wherein the pump comprises a cassette having a first inner volume for flowing at least one of the first fluid and the second fluid, further comprising: (i) replacing the cassette with an additional cassette having a second inner volume, for flowing at least one of the first fluid and the second fluid, which is different from the first inner volume, (ii) activating the additional cassette to enable the first flow rate and the second flow rate, (iii) setting the target value and recording the readings, (iv) calculating an additional ratio between the readings of the first flow rate and the readings of the second flow rate, and (v) storing the ratio and the additional ratio in a lookup table.
The method according to examples 16 through 22, further including: (i) altering at least one of the first flow rate, and the pressure in the calibration chamber, (ii) calculating an additional ratio between the readings of the first flow rate and the readings of the second flow rate, and (iii) storing the ratio and the additional ratio in a lookup table.
It will be appreciated that the examples described above are cited by way of example, and that the present disclosure is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.
