Patent Application
20250186256
The present disclosure relates to priming of surgical system, and more particularly relates to priming of phacoemulsification system while calibrating pressure of fluid in the system.
Phacoemulsification is a surgical procedure used to treat cataracts, which is associated with clouding of the eye's lens and can cause blurred vision, difficulty seeing at night, and sensitivity to light. during the procedure, a surgeon makes a small incision in the patient's cornea and inserts a probe to emit ultrasonic waves breaking the cataract tissue to small pieces. The pieces of the tissue can be suctioned out of the eye, where an artificial lens can be placed.
Typically, prior to surgical operation, the phacoemulsification undergoes priming and/or tuning to prepare the system for required operation. Priming of the system generally involves filling the phacoemulsification system tubing with irrigation fluid (typically balanced salt solution) and creating vacuum in the system.
The priming process is important for ensuring safety and effectiveness of the surgical operation, it helps prevent air bubbles from entering the eye and reduces surgical risks. Generally, the intraocular pressure (IOP) needs to be closely monitored during the phacoemulsification procedure to avoid damage to the patient's eye as a result of vacuum surge or fluid accumulation. To this end phacoemulsification systems typically include sensors monitoring irrigation and vacuum pressures and adjust the pressures to maintain IOP.
Correspondence between the actual IOP and the readings from the irrigation pressure provided by sensors of the phacoemulsification systems may depend on various factors including distance of the sensors from the tip of the needle, mechanical structure of the handle as well as ambient conditions. This limits the accuracy in determining IOP during the procedure.
As indicated above, priming process generally includes operation of a phacoemulsification system for providing irrigation fluid within respective channels and removing air bubbles from the irrigation channel. During the priming process, the system may also operate to tune one or more sensors thereof, verifying accurate pressure and flow reading during operation. The Present disclosure provides a method and system for priming phacoemulsification systems to enhance accuracy and reproducibility in IOP pressure estimation during the procedure.
More specifically, the present disclosure provides a phacoemulsification system, and a method for use in priming of a phacoemulsification system, utilizing one or more external pressure sensors coupled with or connected to an operation (distal) end of a handpiece of the phacoemulsification system. The one or more external pressure sensors are used for determining fluid pressure during priming of the system, enabling calibration of one or more internal pressure sensors of the system, and allowing direct and accurate control of irrigation and/or aspiration pressure during surgical operation. Accordingly, when the phacoemulsification system operates in a priming mode, typically prior to performing a medical procedure, the system utilizes the one or more external pressure sensors to obtain calibration pressure data and to calibrate pressure output data of the one or more internal sensors. The one or more internal sensors are used for monitoring irrigation and/or aspiration pressures during surgical operation.
In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, examples will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
As indicated above, the present disclosure provides a method and a phacoemulsification system utilizing one or more external sensors operable for calibration pressure sensor during pre-use priming process. Reference is made to
Handpiece 50 may include at least one vibrating element 52, e.g., piezoelectric crystal and corresponding circuitry, and a needle 54 and sleeve 55 located at a distal end of the handpiece 50. Vibrating element 52 is operable for vibrating at a selected frequency to emulsify a lens of a patient's eye during a surgical procedure. Additionally, needle 54 and sleeve 55 may provide a portion of irrigation and aspiration channels to transmit irrigation fluid and to apply aspiration vacuum at the operation site as described in more details below. Handpiece 50 may include one or more sensors 116, internal channels associated with aspiration channel and irrigation channel. Further, handpiece 50 may also include anti-vacuum surge (AVS) module 59 configured to block aspiration flow in response to detection. AVS 59 may be coupled with or connected to sensors 116 for receiving data on pressure and/or flow rate in the irrigation and/or aspiration channels and operate to block aspiration pressure from reaching the patient's eye in response to detecting conditions indicating possible vacuum surge.
In this connection it should be noted that the one or more sensors 116 may be located within the handpiece 50, within the main unit 102, and/or incorporated within the AVS module 59.
The needle 54 and sleeve 55 located at distal end of the handpiece 50 provide irrigation and aspiration to the eye, as well as transmit vibrations to emulsify lens material. Typically, in some examples, irrigation fluid may flow into eye volume through a region between outer wall of the needle 54 and inner wall of the sleeve 55. While in some configurations, aspiration channel may flow through the needle 54.
Generally, handpiece 50 may be electronically coupled with the one or more processors 118 (or PMC as described below) and may provide an interface enabling a physician, scrub nurse, or other operator, to operate the phacoemulsification system and control its operational parameters. The handpiece may be coupled with an operation interface in the form of buttons, dials, touchscreen section, foot pedal etc., enabling a physician to provide operation instructions to the processor 118. More specifically, an operator, being a surgeon, nurse or technician may control and/or program selected operations using the user interface and one or more input methods such as a button, pedal, etc. Certain exemplary configurations of the handpiece are described in U.S. Pat. No. 11,806,465 assigned to the assignee of the present application and incorporated herein by references.
Unit 102 may include irrigation module 112, aspiration module 114, driver module 115 and processor 118. As indicated above, unit 102 may in some configurations include one or more sensors 116. The processor 118 is typically associated with a memory and input/output interface, providing a processor and memory circuitry (PMC). The processor, or PMC 118 is operatively coupled with the input/output interface and configured to provide processing necessary for operating system 100 as further described. The processor 118 can be configured to execute several functional modules in accordance with computer readable instructions stored in the memory and/or implemented via one or more computer readable media. Processor 118 may operate irrigation module 112, aspiration module 114, and driver 115 in accordance with one or more operation schemes determined by an operator (e.g., physician or nurse). As indicated above, the operator may determine an operation scheme and parameters via the user interface including e.g., one or more buttons/pedals as described above.
Phacoemulsification system 100 is configured and operable for performing one or more medical operations, such as cataract operation. The system is further configured for operating in a pre-operation priming and/or tuning mode. In the pre-operation priming and/or tuning mode, phacoemulsification system 100 may operate to prepare the system for operation, typically by flowing fluid through the irrigation and/or aspiration channels and ensuring selected pressure conditions required for suitable operation of the system. To this end, the phacoemulsification system 100 further includes a priming cover (also known as a test chamber) 56 configured to fit on and provide cover to the distal end of the handpiece 50, including covering the needle and sleeve 54 thereof. The priming cover 56 is connected or connectable with one or more external sensors 80, e.g., pressure sensors, via channel 82. The one or more external sensors 80 is configured to provide sensing data indicative of pressure (e.g., fluid pressure) through the priming cover 56 and needle and sleeve 54. The one or more external sensors 80 is connectable to unit 102 to provide output sensing data to the one or more processors 118 thereof. In some examples of the present disclosure, the one or more processors 118 utilize pressure data collected from the one or more external sensors 80 to calibrate the one or more sensors 116 of the system.
Generally, a phacoemulsification system may be used in a cataract procedure. During the procedure, distal end of the handpiece may be directed into a patient's eye through a small incision in the sclera or cornea. The needle of the handpiece may vibrate using the piezoelectric vibrating element 52 to emulsify the lens of the eye. The system is further operated to provide irrigation fluid into the eye, and to aspirate the irrigation fluid together with other fluids in the eye and the emulsified lens, forming together eye fluids, to remove the fluids from the eye. Pressure variation within the patient's eye is preferably minimized to avoid collapse of the cornea and maintain eye structure to avoid surgical complications.
According to some examples of the present disclosure, phacoemulsification system 100 may carry pre-stored computer readable instructions indicative of a priming mode operation. The pre-stored instructions include instructions that when executed by the one or more processors 118, cause the processor to operate the irrigation module 112 and aspiration module 114 for preparing the respective irrigation and aspiration lines extending between unit 102 and handpiece 50 to allow fluid flow between the distal end of the handpiece 50 and the respective modules 112 and 114. The pre-stored instruction also includes instructions to obtain calibration pressure data from the one or more external sensors 80, indicative of pressure detected at the distal end of the handpiece 50, and use the calibration pressure data to calibrate one or more sensors 116.
Connection line 104 may be of a selected length providing maneuverability in position of handpiece 50 to allow a physician to perform the required medical operation. Connection line 104 may include tubing for irrigation and aspiration and additional wiring for communication between the handpiece 50 and unit 102. In some examples, as mentioned above, one or more sensors 116 may be placed within unit 102, and configured for collecting sensing data along the irrigation and/or aspiration channels. In such configurations, length and path of the connection line 104, may result in variation between the pressure measured by sensors 116 and actual pressure at the distal end of handpiece 50.
Additionally, as exemplified in
More specifically, according to some examples, prior to performing a medical operation, phacoemulsification system 100 is operable in priming and/or tuning mode. While operating in priming and/or tuning mode, the system 100 operates the irrigation module 112, typically including at least one pump and coupled with a fluid reservoir (not specifically shown), for pushing fluid through irrigation channel toward the needle 54 and sleeve 55 at the distal end of the handpiece. This is performed to ensure that the irrigation channel is filled with fluid and any air bubbles are removed. Additionally, the system 100 operates the aspiration module 114, typically including at least one pump configured to apply vacuum conditions though the aspiration channel, via needle 54 to pull the fluid introduced by the irrigation module through the aspiration module and remove any air bubbles in the system. Additionally, according to some examples of the present disclosure, at least one processor 118 operates to obtain pressure data from one or more internal sensors 116 and from one or more external sensors 80. The at least one processor further operates to calibrate pressure readout of the one or more pressure sensors 116 in accordance with calibration pressure data obtained from the one or more external sensors 80. The at least one processor 118 may operate to determine a relation, or a function defining a relation between pressure output of the one or more sensors 116 and the pressure data obtained from one or more external sensors 80. For example, in some situations, pressure detected by one or more sensors 116 may be lower (or higher) than pressure detected by one or more external sensors 80 by a fixed pressure difference. In such cases, the determined relation may be determined as P116=P80+ΔP, where P116 is pressure data detected by one or more pressure sensors 116, P80 is pressure data detected by one or more external sensors 80, and ΔP is the detected pressure difference. In some other situations, pressure detected by one or more sensors 116 may be lower (or higher) than pressure detected by one or more external sensors 80 by certain ratio. In such cases, the determine relation may be of the form P116=P80*R, where P116 is pressure data detected by one or more pressure sensors 116, P80 is pressure data detected by one or more external sensors 80, and R is the determine ratio, being smaller or greater than unity. In some situations, the determined relation may be linear, in the form P116=P80*R+ΔP. In some other situations, the determined relation may include a quadratic factor or other factors as determined by the one or more processors 118 during calibration.
After determining the relation between the pressure data measured by the one or more external sensors 80 and one or more sensors 116, the one or more processors 118 may operate to determine a calibration factor, or calibration function, enabling conversion of pressure data determined by one or more sensors 116 and the pressure that is determined by one or more external sensors 80. The at least one processor 118 may operate to store the calibration factor in a respective memory unit, together with instructions on conversion of pressure output from one or more sensors 116 during operation in accordance with the calibration factor. Thus, system 100, or the at least one processor 118 thereof may utilize the calibration factor to adjust output data indicative of fluid pressure obtained from the one or more sensors 116 system during operation to provide data on pressure that is adjusted to pressure at the distal end of the handpiece.
The one or more external sensors 80 may be fully external to phacoemulsification system 100, or be a part of the system. In this connection, the one or more externals sensors 80 may be external in the sense of measuring pressure at an external location, i.e., measure pressure at distal end of the handpiece 50 via priming cover 56. The one or more external sensors 80 may include any type of sensor capable of detecting pressure variation, including for example, capacitive sensors, strain gauge sensor, piezoelectric sensor, bourdon type sensor, manometer sensor, etc.
In this connection, reference is made to
As indicated above, the one or more external sensors 80, and/or water column 84 when used, may be physically external to the phacoemulsification, coupled with the frame of unit 102, or form an integral part of phacoemulsification system 100. In some examples, where the one or more external sensors 80 and/or water column 84, are integral part of the system, the one or more sensors are external in the meaning that the sensors 80 are connected to determine pressure data at the distal end of handpiece 50, through priming cover 56.
Additionally, priming cover 56, together with at least one or more channels (tubes) 82, connecting the priming cover to the one or more external sensors 80 and/or to water column 84, may be sterilized prior to use. Accordingly, in some examples, a priming kit, including at least a priming cover 56 connected via channel 82 to one or more externals sensors 80 may be used separately from phacoemulsification system 100. This is exemplified in
In some examples, the water column 84 may be sufficiently tall to enable pressure measurements with a working range of 700 mmHg, to thereby enable pressure measurement within a typical working pressure range of the phacoemulsification system. In some other examples, the height of the water column may be reduced, to provide a relatively compact system. Accordingly, for the case of a reduced height water column 84, the present technique may utilize one or more approximation techniques to determine pressure variations, such as assuming linearity in pressure variation and water level and extrapolate actual pressure from the water column level.
Additionally, in some examples, the water column 84 may include one or more apertures 86 associated with one or more flow meters 88 located at top end of the water column 84. In these examples, one or more external sensors 80 may be associated with flow meter 88 located at the one or more apertures of the water column 84 to provide data indicative of pressure, and pressure variations, in accordance with air flow into or out of the water column 84 in response to variation in water level. Detection of air flow through one or more apertures of the water column 84 enables sufficient working range, while enabling reduced height of the water column 84.
Further, reference is made to
This method provides for calibrating one or more sensors of the phacoemulsification system using pressure data collected by the one or more sensors of the system and the one or more external sensors. As indicated above, pressure data collected by one or more sensors of the system (e.g., sensors 116 in
As indicated above, in some examples, the actions 4010 and 4020 may include connecting a phacoemulsification system with a kit including priming cover as described in
After priming, the phacoemulsification system may be ready for use in a medical procedure. During the medical procedure, the method may include obtaining pressure data from the system sensors and converting the pressure data in accordance with the stored calibration factor at step 5090. This provides output pressure data calibrated to pressure that would be measured at the distal end of the handpiece, where the system interfaces with a patient's eye. Accordingly, the method of the present disclosure may be used to enhance accuracy and reproducibility of pressure data during a medical operation using a phacoemulsification system, to eliminate, or at least significantly reduce complications during the medical procedure.
The present disclosure thus provides for a phacoemulsification system and a method for use in priming of a phacoemulsification system. The present technique utilizes one or more external sensors, in the meaning of measuring pressure at the distal end of the handpiece via a priming cover, for calibrating the system sensors using the pressure data collected.
It is to be noted that the various features described in the various examples can be combined according to all possible technical combinations.
It is to be understood that the invention is not limited in its application to the details set forth in the description contained herein or illustrated in the drawings. The invention is capable of other examples and of being practiced and carried out in various ways. Hence, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception upon which this disclosure is based can readily be utilized as a basis for designing other structures, methods, and systems for carrying out the several purposes of the presently disclosed subject matter.
Those skilled in the art will readily appreciate that various modifications and changes can be applied to the examples of the invention as hereinbefore described without departing from its scope, defined in and by the appended claims.
