Patent Description:
During ophthalmic surgery, an ophthalmic surgical apparatus is used to perform surgical procedures in a patient's eye. An ophthalmic surgical apparatus typically includes a handheld medical implement or tool, such as a handpiece having a tip and/or sleeve at the distal end, and operating controls for regulating settings or functions of the apparatus and tool. Operation of the tool requires control of various operating settings or functions based on the type of tool used. Such apparatuses typically include a control module, power supply, an irrigation source, one or more aspiration pumps, as well as associated electronic hardware and software for operating a tool. The handpiece may include a needle or tip which is ultrasonically driven once placed with the incision to, for example, emulsify the lens of the eye. In various surgical procedures, these components work together in order to, for example, emulsify eye tissue, irrigate the eye with a saline solution, and aspirate the emulsified lens from the eye.

An exemplary type of ophthalmic surgery is phacoemulsification. Phacoemulsification includes making a corneal and/or scleral incision and the insertion of a phacoemulsification handpiece that includes a needle or tip that is ultrasonically driven to emulsify, or liquefy, the lens. A phacoemulsification system typically includes a handpiece coupled to an irrigation source and an aspiration pump. The handpiece includes a distal tip that emits ultrasonic energy to emulsify a crystalline lens within the patient's eye. The handpiece includes one or more irrigation ports proximal to the distal tip and coupled to the irrigation source via an irrigation input line. The handpiece further includes an aspiration port at the distal tip that is coupled to the aspiration pump via an aspiration output line. Concomitantly with the emulsification, fluid from the irrigation source (which may be a bottle or bag of saline solution that may be elevated above the patient's eye, to establish positive pressure by gravity, and/or with external pressure source) is irrigated into the eye via the irrigation line and the irrigation port(s). This fluid is directed to the crystalline lens in the patient's eye in order to maintain the anterior chamber and capsular bag and replenish the fluid aspirated away with the emulsified crystalline lens material. The irrigation fluid in the patient's eye and the crystalline lens material is aspirated or removed from the eye by the aspiration pump and line via the aspiration port. In some instances, the aspiration pump may be in the form of, for example, a peristaltic or positive displacement pump. Other forms of aspiration pumps are well known in the art, such as vacuum pumps, e.g. Venturi pump. In addition, more than one pump or more than one type of pump may be used. Additionally, some procedures may include irrigating the eye and aspirating the irrigation fluid without concomitant destruction, alteration or removal of the lens.

Intraocular pressure (IOP) is the fluid pressure inside the anterior chamber of the eye. In a normal eye, intraocular pressure may vary depending on the time of day, activities of the patient, fluid intake, medications, etc. Intraoperative intraocular pressure may be measured as static (a specific value) or dynamic (a range of values). As can be appreciated, the static IOP and dynamic IOP of a patient's eye can fluctuate greatly during an ophthalmic surgery procedure. It is well known that the IOP in an anterior chamber of the eye is required to be controlled and maintained during such surgical procedures in order to avoid damage to the patient's eye. For the correct function of the eye and its structure (e.g. shape) and to preserve sharp and undamaged vision, it is very important to maintain the intraoperative IOP.

Different medically recognized techniques have been utilized for ophthalmic surgery, such as phacoemulsification, in order to maintain and control the intraoperative IOP of a patient's eye. In various examples, phacoemulsification may involve combining irrigation, aspiration and emulsification within a single handpiece. The handpiece that is typically controlled electrically in order to, for example, control the flow of fluid through the handpiece and tip. As may be appreciated, during a surgical procedure, the flow of fluid to and from a patient's eye (through a fluid infusion/irrigation system or aspiration/extraction system, for example), the fluid pressure flowing through the handpiece, and the power control over the handpiece, are all critical to the procedure performed. Precise control over aspiration and irrigation to the crystalline lens is desired in order maintain a desired or optimal intraoperative IOP within the anterior chamber of the eye. Similarly, it may be necessary to maintain a stable volume of liquid in the anterior chamber of the eye, which may be accomplished by irrigating fluid into the eye at the same rate as aspirating fluid and lens material from the eye. Accordingly, the ability to predict or determine the static IOP and dynamic IOP of a patient's eye during a surgical operation would be beneficial to a surgeon or operator of such a surgical apparatus.

In prior ophthalmic surgical devices, the control and settings of the system may be electronically controlled or modified by use of a computer system, control module and/or a user/surgeon. For instance, the control module may also provide feedback information to a user or surgeon regarding the function and operation of the system, or may also receive input from a user or surgeon in order to adjust surgical settings. A surgeon or user may interface with a display system of the control module during use of the device.

Additionally, a surgeon or user may control or adjust certain aspects of the intraoperative IOP by adjusting various settings or functions of the system. For instance, the irrigation source may be in the form of a suspended or lifted saline bottle or bag, and the surgeon is typically able to adjust the height of the bottle or bag to create a specific head height pressure of the fluid flowing from the bottle or bag. In typical systems, the head height pressure, which is a function of the column height, is the static IOP of the fluid flowing through the patient's eye. Accordingly, the surgeon may be able to indirectly set the static IOP by changing the bottle height to a desired level. However, dynamic IOP is a function of surgical parameters and the surgical environment during surgery. Currently, ophthalmic systems do not provide any means for measuring or predicting dynamic IOP.

Even further, prior phacoemulsification systems do not provide a process to manage IOP during post occlusion surge thereby affecting anterior chamber stability. Further, prior phacoemulsification systems do not provide any indication of occlusion or post occlusion surge events.

Current phacoemulsification systems, both based on peristaltic and Venturi systems may not provide suitable methods of managing IOP during post occlusion surge, often resulting in uncontrolled changes to the stability of the anterior chamber. More specifically, current Venturi based systems, including those using a gravity based infusion system, may not provide any indication(s) relative to post occlusion surge events. For example, if a phacoemulsification needle tip is occluded with cataract material, a high vacuum state may be created within the outflow tubing. This high vacuum level may at least partially collapse the walls of the elastic tubing, and, once the occlusion breaks, the walls of the tubing may rebound back into shape, rapidly sucking fluid from the eye and creating a surge. Because the volume of the anterior and posterior chambers are so small, a slight collapse in the length of the long outflow tubing may create a significant surge and increase the risk for collapse of the eye and aspiration of the posterior capsule during surgery. Thus, the management and quantification of IOP and occlusion, and post occlusion surge detection, may provide improved fluidics control during phacoemulsification surgery and may lead to better surgical outcomes by improving anterior chamber stability and more reliable surgical systems.

Based on the foregoing, it would be advantageous to provide a means for determining both the static IOP and dynamic IOP of a patient's eye throughout a surgical operation. Further, it would be advantageous to provide a means for determining a total IOP for the patient's eye from the static IOP, dynamic IOP, and/or other variables of the surgical operation. Such a design would afford a surgeon the ability to perform desired phacoemulsification, diathermy, or vitrectomy functions with better understanding of the surgical environment and process during the surgical procedure.

<CIT> discloses a surgical system comprising a pressurized irrigation fluid source; an irrigation line fluidly coupled to the pressurized irrigation fluid source; a hand piece fluidly coupled to the irrigation line; an irrigation pressure sensor located at or along the pressurized irrigation fluid source or irrigation line; and a controller for controlling the pressurized irrigation fluid source. The controller controls the pressurized irrigation fluid source based on a reading from the irrigation pressure sensor and an estimated flow value modified by a compensation factor.

<CIT> discloses an irrigation system for a medical device. The irrigation system may include a pump that can pump irrigation fluid from a reservoir through an irrigation line. The system may further have a controller coupled to the pump and an accumulator pressure sensor that senses the pressure of the irrigation line. The controller can vary the speed of the pump in response to a change in the line pressure to control the irrigation line pressure. Additionally, the controller can monitor the fluidic resistance of the system by determining the pump speed and corresponding flowrate of the pump. The controller can provide one or more safety output signals if the fluidic resistance exceeds a threshold value(s).

<CIT> discloses systems and methods for fluid control, and more particularly to systems and methods for power and flow rate control for aspiration. In accordance with one embodiment, an aspiration system includes an aspiration line having distal and proximal ends and an aspiration port defined in the distal end; a fluid transport device operatively coupled to the proximal end of the aspiration line; and a flow restrictor operatively coupled to the aspiration line in between the fluid transport device and the aspiration port. To measure occlusion within the line, first and second pressure sensors are utilized, the first sensor being operatively coupled to the aspiration line between the port and the restrictor and the second sensor being operatively coupled to the aspiration line between the restrictor and the fluid transport device. The pressure differential between the two sensors can provide an indication of the onset, presence, and/or elimination of an occlusion.

The present invention provides a system as defined in claim <NUM>. Optional features are recited in the dependent claims. The system tool of the present invention can be used in the methods described herein (which are not explicitly recited in the wording of the claims).

The organization and manner of the structure and function of the disclosure, together with the further objects and advantages thereof, may be understood by reference to the following description taken in connection with the accompanying drawings, and in which:.

The following description and the drawings illustrate specific embodiments sufficiently to enable those skilled in the art to practice the described system and method. Other embodiments may incorporate structural, logical, process and other changes. Examples merely typify possible variations. Individual components and functions are generally optional unless explicitly required, and the sequence of operations may vary. Portions and features of some embodiments may be included in or substituted for those of others.

A system and method for receiving and/or detecting certain variables of a surgical system and utilizing those variables to predict an intraoperative intraocular pressure (IOP) and/or determine an IOP in real time during a surgical procedure to either provide a notification to a surgeon or allow a target IOP of the anterior chamber of a patient's eye to be set and maintained may be determined by Static IOP, dynamic IOP, and/or a total IOP combining both static and dynamic IOP of the anterior chamber of a patient's eye, which can be applied to any type of system, are disclosed herein. For example, the IOP may be segmented into static and dynamic during a phacoemulsification procedure, static IOP being primarily impacted by the fluid inflow with small amount of outflow and dynamic IOP being primarily impacted by fluid outflow. In illustrative embodiments, the system and method include means for calculating the static IOP, dynamic IOP, and/or total IOP through information provided by a user (e.g. a surgeon) of the system or information collected by a control module of the system. In illustrative embodiments, the system and method include a graphical user interface or other user interface that permits a user to insert information about various components of the system. In other illustrative embodiments, the system can determine various parameters of the system through internal sub-systems (e.g. sensors) to collect information about various components of the system and display such information on the user interface. The system may use such information to calculate the static IOP and/or dynamic IOP of the system, and the total IOP may be function of the static IOP and/or dynamic IOP measurements. In addition, as will be discussed additional parameters or factors may also be considered in determining a total IOP.

As discussed herein, a stable intraoperative IOP may be of critical importance in order to maintain a stable anterior chamber pressure during phacoemulsification. A stable intraoperative IOP may be a function of fluid inflow and outflow such that the volume, and in turn the pressure of anterior chamber, remains stable when a chamber is at or near equilibrium.

Further, parameters directed towards IOP, occlusion, and post occlusion surge detection would provide a better fluidics control and in turn lead to improved anterior chamber stability, thereby providing comfort to a patient, an operating surgeon and ensure safety while using phacoemulsification systems.

Embodiments of a subsystem and method will be discussed herein with a particular emphasis on a medical or hospital environment where a surgeon or health care practitioner performs. For example, an embodiment is a phacoemulsification surgical system that comprises an integrated high-speed control module for a phacoemulsification or vitrectomy handpiece that is configured to be inserted into a patient's eye during the phacoemulsification procedure. The system may further comprise one or more sensor(s) to detect variables about the function and operation of the system, such as the rate of fluid flow before and after the fluid flows through the handpiece, and a processor that can collect such variables and/or receive additional variables as inputs from a user, in order to determine the static IOP and dynamic IOP of the anterior chamber of the patient's eye during surgery. The system may further comprise a processor that may control, adjust or set various characteristics of the system to control a phacoemulsification or a high-speed pneumatic or electronic vitrectomy handpiece based on the static IOP and/or dynamic IOP measurements determined.

<FIG> and <FIG> illustrate an exemplary phacoemulsification/diathermy/vitrectomy system <NUM>. As illustrated, the system <NUM> includes, for example, a handpiece or wand <NUM>, an irrigation source <NUM>, an aspiration source <NUM>, an optional pressure supply <NUM>, and a control module <NUM>. In illustrative embodiments, fluid is controllably directed through the system <NUM> in order to irrigate a patient's eye, illustrated representatively at <NUM>, during an ocular surgical procedure. Various embodiments of the handpiece <NUM>, irrigation source <NUM>, aspiration source <NUM>, optional pressure supply <NUM> and control module <NUM> are well known in the art and are embodied in this disclosure.

As illustrated in <FIG> and <FIG>, the irrigation source <NUM> is configured to supply a predetermined amount of fluid to the handpiece <NUM> for use during a surgical operation. Such fluid is supplied in order to, for example, stabilize or maintain a certain IOP in the anterior chamber of the eye during surgery, as well as provide means for fluidly transporting any particles (e.g. lens particulates that are created during emulsification) out of the eye. Various aspects (e.g. the flow rate, pressure) of fluid flow into and out of the anterior chamber of the eye will typically affect the operations of the surgical procedure and in particular the IOP measurements of the anterior chamber of the eye during the surgical procedure.

In illustrative embodiments, fluid may flow from the irrigation source <NUM> to the handpiece <NUM> via an irrigation line <NUM>. The irrigation source <NUM> may be any type of irrigation source <NUM> that can create and control a constant fluid flow. In illustrative embodiments, the irrigation source is elevated to a predetermined height via an extension arm <NUM>. In illustrative embodiments, the irrigation source <NUM> may be configured to be an elevated drip bag <NUM>/<NUM> that supplies a steady state of fluid <NUM> to the irrigation line <NUM>. The pressure supply <NUM> may be coupled to the irrigation source <NUM> in order to maintain a constant pressure in the irrigation source <NUM> as fluid exits the irrigation source <NUM>, as is known in the industry. Other embodiments of a uniform irrigation source are well known in the art.

During the surgical procedure, it is typically necessary to remove or aspirate fluid and other material from the eye. Accordingly, fluid may be aspirated from the patient's eye, illustrated representatively at <NUM>, via the handpiece <NUM> to flow through an aspiration line <NUM> to the aspiration source <NUM>. The aspiration source <NUM> may be any type of aspiration source <NUM> that aspirates fluid and material from the eye. In illustrative embodiments, the aspiration source <NUM> may be configured to be a flow-based pump <NUM> (such as a peristaltic pump) or a vacuum-based pump (such as a Venturi pump) that are well known in the art. The aspiration source <NUM> may create a vacuum system to pump fluid and/or material out of the eye via the aspiration line <NUM>. Other embodiments of an aspiration source are well known in the art.

The irrigation port <NUM> is fluidly coupled to the irrigation line <NUM> to receive fluid flow from the irrigation source <NUM>, and the aspiration port <NUM> is fluidly coupled to the aspiration line <NUM> to receive fluid and/or material flow from the eye. The handpiece <NUM> and the tip <NUM> may further emit ultrasonic energy into the patient's eye, for instance, to emulsify or break apart the crystalline lens within the patient's eye. Such emulsification may be accomplished by any known methods in the industry, such as, for example, a vibrating unit (not shown) that is configured to ultrasonically vibrate and/or cut the lens, as is known in the art. Other forms of emulsification, such as a laser, are well known in the art. Concomitantly with the emulsification, fluid from the irrigation source <NUM> is irrigated into the eye via the irrigation line <NUM> and the irrigation port <NUM>. During and after such emulsification, the irrigation fluid and emulsified crystalline lens material are aspirated from the eye by the aspiration source <NUM> via the aspiration port <NUM> and the aspiration line <NUM>. Other medical techniques for removing a crystalline lens also typically include irrigating the eye and aspirating lens parts and other liquids. Additionally, other procedures may include irrigating the eye and aspirating the irrigating fluid within concomitant destruction, alternation or removal of the lens.

The aspiration source <NUM> is configured to aspirate or remove fluid and other materials from the eye in a steady, uniform flow rate. Various means for steady, uniform aspiration are well known in the art. In illustrative embodiments, the aspiration source <NUM> may be a Venturi pump, a peristaltic pump, or a combined Venturi and peristaltic pump. In illustrative embodiments, and as shown in <FIG>, a peristaltic pump <NUM> may be configured to include a rotating pump head <NUM> having rollers <NUM>. The aspiration line <NUM> is configured to engage with the rotating pump head <NUM> as it rotates about an axis. As the pump head <NUM> rotates the rollers <NUM> press against the aspiration line <NUM> causing fluid to flow within the aspiration line <NUM> in a direction of the movement for the rollers <NUM>. Accordingly, the pump <NUM> directly controls the volume or rate of fluid flow, and the rate of fluid flow can be easily adjusted by adjusting the rotational speed of the pump head <NUM>. Other means of uniformly controlling fluid flow in an aspiration source <NUM> are well known in the art. When the aspiration source <NUM> includes a combined Venturi and peristaltic pump, the aspiration source <NUM> may be controlled to automatically switch between the two types of pumps or user controlled to switch between the two types of pumps.

In illustrative embodiments, the control module <NUM> is configured to monitor and control various components of the system <NUM>. For instance, the control module <NUM> may monitor, control, and provide power to the pressure supply <NUM>, the aspiration source <NUM>, and/or the handpiece <NUM>. The control module <NUM> may be in a variety of forms as known in the art. In illustrative embodiments, the control module <NUM> may include a microprocessor computer <NUM>, a keyboard <NUM>, and a display or screen <NUM>, as illustrated in <FIG>, 2A, <FIG>, <FIG> and <FIG>. The microprocessor computer <NUM> may be operably connected to and control the various other elements of the system, while the keyboard <NUM> and/or display <NUM> permit a user to interact with and control the system components as well. In an embodiment a virtual keyboard on display <NUM> may be used instead of keyboard <NUM>. In illustrative embodiments, the control module <NUM> may also include a pulsed ultrasonic power source (not shown) that can be controlled by the computer <NUM> in accordance with known methods or algorithms in the art. A system bus <NUM> may be further provided to enable the various elements to be operable in communication with each other.

The screen <NUM> may display various measurements, criteria or settings of the system <NUM> - such as the type of procedure, the phase of the procedure and duration of the phase, various parameters such as vacuum, flow rate, power, and values that may be input by the user, such as bottle height or infusion pressure, sleeve size, tube length (irrigation and aspiration), tip size, vacuum rate, etc., as illustrated in <FIG>. The screen <NUM> may be in the form of a graphical user interface (GUI) <NUM> associated with the control module <NUM> and utilizing a touchscreen interface, for example. The GUI <NUM> may allow a user to monitor the characteristics of the system <NUM> or select settings or criteria for various components of the system. For instance, the GUI <NUM> may permit a user to select or alter the maximum pressure being supplied by the pressure supply <NUM> to the irrigation source <NUM> via line <NUM>. The user may further control the operation of the phase of the procedure, the units of measurement used by the system <NUM>, or the height of the irrigation source <NUM>, as discussed below. The GUI <NUM> may further allow for the calibration and priming of the pressure in the irrigation source <NUM>.

In illustrative embodiments, the system <NUM> may include a sensor system <NUM> configured in a variety of ways or located in various locations. For example, the sensor system <NUM> may include at least a first sensor, e.g. a strain gauge, <NUM> in communication with the irrigation line <NUM> and a second sensor, e.g. a strain gauge, <NUM> in communication with the aspiration line <NUM>, as illustrated for example in <FIG>. Other locations for the sensors <NUM> and <NUM> are envisioned anywhere in the system <NUM> and may be in communication with one or more irrigation and/or aspiration lines via different mechanism, e.g. on the handpiece <NUM>, at an end of the handpiece <NUM>, proximate or near the end of the handpiece <NUM>, on or within the surgical console, within one or more irrigation lines and/or an aspiration lines and/or portions thereof, attached to or otherwise coupled with one or more irrigation and/or aspiration lines, resident in line with one or more irrigation and/or aspiration lines, etc., and may be configured to determine a variety of variables that may be used to determine intraoperative IOP measurements in the eye, as discussed below. This information may be relayed from the sensor system <NUM> to the control module <NUM> to be used in the determination of IOP measurements. The sensor system <NUM> may also include sensors to detect other aspects of the components used in the system, e.g. type of pump used, type of sleeve used, gauge of needle tip (size), etc. In another embodiment, the sensor system <NUM> may include only a first sensor located along the irrigation line <NUM> or the aspiration line <NUM>.

In order to determine the IOP of a patient's eye during surgery, the system <NUM> may be configured to determine and/or receive a variety of variables about the system <NUM> that may be used in a predictive algorithm to determine the IOP range before the surgery begins or provide the IOP during surgery based on the entered parameters and/or sensed parameters. The algorithm may be performed on the control module <NUM> and takes into account one or more of the parameters, such as bottle height, tip size, sleeve size, aspiration rate, vacuum rate, length and compliance metrics of various tubing used in the system, and/or pump rate, as will be described below. Other parameters for consideration in the algorithm are envisioned within the scope of this disclosure. Specifically, the following algorithms alone or in combination in addition to other parameters discussed below may be used to determine IOP measurements: <MAT> <MAT>.

The variables of these algorithms will now be discussed.

One factor for consideration in the determination of IOP measurement is the bottle height of the irrigation source <NUM>. As illustrated in <FIG>, the irrigation source <NUM>, specifically the exit port <NUM> of the irrigation source, is typically elevated to a predetermined height H. This predetermined elevation may be accomplished by any known means. For example, the irrigation source <NUM> may be connected to one or more fixed supports <NUM> on the extension arm <NUM>, the fixed supports spaced at varying heights H1 and H2 along the extension arm <NUM> to permit the irrigation source <NUM> to hang down via the force of gravity and place the exit port <NUM> of the irrigation source <NUM> at predetermined height H. Alternatively, the extension arm <NUM> may be retractable (or movable) relative to a fixed receiver <NUM>, the extension arm <NUM> including biased retaining members <NUM> that can engage with an aperture (not shown) of the fixed receiver <NUM> to maintain the extension arm <NUM> in a relative position with respect to the fixed receiver <NUM>. In such an embodiment, the height H of the exit port <NUM> of the irrigation source <NUM> (with respect to the ground) may be maintained in the predetermined position based on the specific retaining member <NUM> engaging with the aperture of the fixed receiver <NUM>, as is known in the art. Other means of height adjustment are known in the art.

The bottle height may be inputted manually into the control module <NUM> of the system by a user via a graphical user interface <NUM>. Alternatively, the bottle height may be determined by the control module <NUM> automatically and displayed on the graphical user interface <NUM>. For example, a sensor system (not shown) may be connected to the extension arm <NUM> or the fixed receiver <NUM> to determine the height H of the exit port <NUM>.

Another factor for consideration in the determination of IOP measurement is the size of a sleeve <NUM> around needle <NUM>. The size of a sleeve or dimension of a sleeve can be a factor in the amount of fluid that flows from irrigation source <NUM> into the eye.

The size of the sleeve <NUM> may be inputted manually into the control module <NUM> of the system by a user via a graphical user interface <NUM>. Alternatively, the size of the sleeve <NUM> may be determined automatically by the control module <NUM> and displayed on the graphical user interface <NUM>. For example, a sensor system (not shown) may be connected to the handpiece <NUM> and/or near the sleeve <NUM>. During a calibration or prime and tune cycle of the system <NUM>, the system may be able to determine the size of the sleeve <NUM> by comparing information received from the sensor, e.g. on the amount of fluid flow out of the sleeve based on the height of the bottle or the flow rate if a pressurized system is used. For example, the sleeve size may be based on the gauge of the needle used or selected independently of the needle selected. Where a basic level of IOP is to be determined, a static IOP may be a function of fluid inflow only, where fluid inflow is governed by the column height of the bottle (bottle height) and wound leakage. As discussed herein, column height of the fluid may be governed by IV bottle height or other pressurizing source such as, for example, vented gas forced infusion (VGFI) and/or incision wound leakage. By way of example, as the height of the IV bottle changes, the static IOP would change accordingly. A surgeon may therefore set the desired static IOP before and during the surgery by adjusting the bottle height or other pressurizing source. The pressure exerted by the bottle height of the fluid is governed by following function: <MAT>.

Assuming that the amount of wound leakage is governed by the size of incision, the static IOP = function {Bottle Height, Wound Leakage}. Using this function, the system may determine the bottle height by measuring the IV pole height or input pressure of the pressurizing source.

Additional parameters may be considered in determining IOP. During phacoemulsification, for example, the IOP of the anterior chamber may vary as lens fragments are emulsified and aspirated from the anterior chamber of the eye. Such variability is a result of the dynamic nature of intraocular pressure during the phacoemulsification procedure. Dynamic IOP may be governed by the flow or aspiration rate. During a procedure, flow and vacuum rates may change as fragments are emulsified and aspirated. This may cause changes in volume of the anterior chamber which in turn may cause the IOP to vary. Thus, the Total IOP may take into account Static IOP parameters and Dynamic IOP parameters. The Total IOP may be predicted before the surgery and also may be determined during surgery based on real time measurements. In addition, a target IOP a surgeon would like to maintain in a patient's eye may be set and the system may adjust various system components or parameters based on sensed data used to calculate periodic Total IOPs during the surgery to maintain the target IOP. Thus, based on the example described above, the Total IOP = Static IOP function {Bottle Height, Wound Leakage} + Dynamic IOP function {Flow Rate/Aspiration Rate}. Using this algorithm, the system may determine the bottle height by measuring IV pole height or input pressure of the pressurizing source. Wound leakage may be determined by the size of the incision made during the surgery. Further, the system may determine fluid outflow by measuring the flow rate at the aspiration line. Moreover, based on the system calculating the Total IOP at various time points before and/or during the procedure a target IOP may be maintained by adjusting one or more parameters, e.g. irrigation flow rate, bottle height, aspiration rate, etc..

A predictive IOP algorithm may be further optimized to provide a more accurate prediction of Total IOP during surgery by taking into account additional parameters, such as the tip and sleeve sizes along with the compliance and length of the associated tubing apparatus. Such an algorithm may use the above stated parameters to provide one or more IOP measurements before and/or during surgery. Thus, the Total IOP = Static IOP {fluid inflow} + Dynamic IOP {fluid outflow}; wherein fluid inflow = function {bottle height or input pressure, sleeve size, wound leakage, length of the irrigation tubing, and inside diameter of irrigation tubing} and fluid outflow = function {flow/aspiration rate, vacuum rate, tip size, compliance, length and inside diameter of aspiration tubing}.

Bottle height may be obtained by measuring the IV pole height and/or input pressure of the pressurizing source and the patient eye level is input prior to the surgery and does not change during the surgery. Generally, the sleeve size is fixed during the surgery and a user may either provide the type and size of the sleeve used or the system may infer this value by measuring the out flow from the sleeve during the prime and tune processes. Flow rate may be variable during a surgery and the system may obtain a flow rate value by measuring the flow of fluid through the aspiration line, while a maximum aspiration rate is generally preset by a user prior to starting a surgery. The vacuum rate may be variable during the surgery and the system may obtain a value for the vacuum rate by measuring the running vacuum during surgery. The length of the irrigation/aspiration (I/A) tubing is generally defined as the distance from the end of the hand piece to the pack or cassette. The system may infer this value from the type of pack used. Compliance of the I/A tubing may be defined for each type of pack such as, for example, a single-use pack or multi-use pack. The system may infer this value from type of pack used. Similarly, the inside diameter of the I/A tubing may be defined for each type of pack, which value may be inferred from type of pack used.

Another factor for consideration in the determination of IOP measurement is tip size. In illustrative embodiments, the tip <NUM> of the handpiece <NUM> may be interchangeable with several other interchangeable tips <NUM> that have different features or characteristics. These tips <NUM> may have predetermined or uniform shapes and port sizes/locations based on the specific tip selected, so that a certain tip size is an industry standard and is known to have industry standard dimensions and features. Each of the different tip sizes may include or provide benefit in the way of different features that assist with performing the surgical operation. Such tips <NUM> are generally known to be of uniform sizes or types in the industry, such that certain tips <NUM> may be considered advantageous for certain surgical maneuvers or operations. Tips of uniform size or type may be identified by specific name or product number to be an industry standard design. Surgeons or other users of such tips may have industry knowledge of the types of tips available and their varying characteristics, and may rely on the uniformity of tip types from operation to operation.

The tip size may be inputted manually into the control module <NUM> of the system <NUM> by a user via the graphical user interface <NUM>. Alternatively, the tip size may be determined by the control module <NUM> automatically and displayed on the graphical user interface <NUM>. In this regard, applicant refers to <CIT>.

Other factors for consideration in the determination of IOP measurement are the characteristics of the irrigation and aspiration lines <NUM>, <NUM> (e.g. tubing). As illustrated in <FIG> and <FIG>, the irrigation line <NUM> connects the irrigation source <NUM> to the handpiece <NUM> and delivers fluid to the handpiece <NUM>, and the aspiration line <NUM> connects the handpiece <NUM> to the aspiration source <NUM> and removes fluid from the eye via the handpiece <NUM>. These lines <NUM>, <NUM> typically comprise flexible tubing that permits a wide variety of relative movement of the handpiece <NUM> with respect to the irrigation source <NUM> and aspiration source <NUM>. The flexible tubing selected for the system may include a variety of lengths and diameters. The length of tubing between the irrigation source <NUM> and the handpiece <NUM>, and the handpiece <NUM> and the aspiration source <NUM>, affects the fluid flow and fluid pressure when the fluid enters/leaves the patient's eye. Similarly, the inside diameter of the tubing affects the fluid flow and fluid pressure when the fluid enters/leaves the eye. Similar to the dimensions of the irrigation line <NUM> and aspiration line <NUM>, the composition of the lines may also affect the flow or pressure of fluid into and out of the patient's eye. Tubing is typically required to meet certain industry standards of compliance, and further be identified based on the compliance requirements of the tubing. The composition (e.g. type of material used to form the tubing) may have certain characteristics (such as compression strength, pliability, etc.) that affect the fluid flow and fluid pressure of fluid flowing into or leaving the patient's eye.

The characteristics of the irrigation and aspiration tubing may be inputted manually into the control module <NUM> of the system <NUM> by a user via the graphical user interface <NUM>. Alternatively, a user may be able to select specific tubing based on predetermined requirements identified by the system <NUM> once a desired IOP is determined. A sensor system (not shown) may exist to determine the compliance, length and diameter of the tubing, alternatively.

Other factors for consideration in the determination of IOP measurement are the characteristics of the aspiration source <NUM>, including the aspiration rate (e.g. rate fluid is aspirated from the eye), vacuum rate (e.g. rate of the vacuum in the aspiration source). The characteristics of the aspiration source <NUM> may be inputted manually into the control module <NUM> of the system <NUM> by a user via the graphical user interface <NUM>, may be preprogrammed in the system, or may be determined by a sensor system (not shown) located along the aspiration line <NUM> or in the aspiration source <NUM>.

In any of the embodiments described herein, any number of the parameters may be used or values entered by a user or considered by the algorithm when calculating a Total IOP. The more parameters used the more accurate the Total IOP is likely to be.

<FIG> illustrate exemplary embodiments of a graphical user interface <NUM> that permits collection and/or display of variables that can affect the static IOP and dynamic IOP when calculating a Total IOP measurement. A variety of methods of collecting and/or displaying information may be encompassed in this disclosure. For example, <FIG> illustrates a single-screen IOP calculation on GUI <NUM>, permitting a user to insert two parameters related to the algorithms to calculate a basic Total IOP measurement, as discussed above, and presenting the resulting Total IOP measurement determined from the algorithm calculation. <FIG> illustrates a single-screen IOP calculation on GUI <NUM>, permitting a user to insert values for the parameters for both Static IOP and Dynamic IOP to calculate a Total IOP measurement as discussed above, and presenting the resulting Total IOP measurement determined from the algorithm calculation. <FIG> illustrates a single-screen IOP calculation on GUI <NUM>, permitting the user to input values for one or more parameters for the Static IOP and/or Dynamic IOP, in addition to the option of entering the patient eye level, to calculate a Total IOP measurement discussed above, and presenting the resulting Total IOP measurement determined from the algorithm calculation. It is also envisioned that each time an IOP calculation is made during surgery it is displayed to a user. In an embodiment, should a target IOP or target range of IOPs be set by a user a visual and/or audible signal can be made to alert the user when the measured IOP falls outside a preset range of the selected or preselected target IOP or target range of IOPs. In addition, to the signal, the system may automatically adjust system parameters to bring the patient's IOP back to the target IOP or within the selected target range of IOP.

<FIG> illustrates means for calculating the total IOP on the GUI <NUM> as a function of the static IOP measurement, the dynamic measurement, and an optical variable related to wound leakage that may be inputted by a user of the system.

Those of skill in the art will recognize that any step of a method described may be interchanged with another step. Those of skill in the art would further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both.

The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed using a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.

Any options available for a particular medical device system may be employed. For example, with a phacoemulsification system the available settings may include, but are not limited to, irrigation, aspiration, vacuum level, flow rate, pump type (flow based and/or vacuum based), pump speed, ultrasonic power (type and duration, e.g. burst, pulse, duty cycle, etc.), irrigation source height adjustment, linear control of settings, proportional control of settings, panel control of settings, and type (or "shape") of response.

In illustrative embodiments, the interface provides feedback to the user should the predetermined or automatic settings, variables, or criteria need adjustment to ensure all the desired settings of the system. The interface can then permit the user to change or modify those settings accordingly.

Other mechanisms for setting and/or programming a particular setting may be employed, including, but not limited to, clicking on an icon on a display screen using a mouse or touch screen, depressing a button/switch on a foot pedal, voice activated commands and/or combinations
thereof.

Irrigation pressure and/or aspiration vacuum at, or in near proximity to, the phacoemulsification hand piece may be measured in real time. Existing phacoemulsification handpieces do not provide a method to measure pressure on or within the irrigation and/or aspiration lines. Measuring pressure on the irrigation and/or aspiration lines in close proximity to the phacoemulsification handpiece may allow for more accurate and precise estimation of the pressure at the surgical site, such as in, for example, a patient's anterior chamber of the eye. More accurate pressure and vacuum measurements, for example, may be utilized to develop algorithms to provide more robust fluidics control during phacoemulsification surgery which may lead to the improvement of anterior chamber stability. This, in turn, may provide additional comfort to the patient, control over the surgical parameters to the operating surgeon, and ensure safer operation of peristaltic and/or Venturi based pumps during phacoemulsification surgery.

An in-line irrigation pressure sensor and aspiration vacuum sensor may be located on or proximate to the hand piece may provide real-time irrigation and aspiration vacuum data. The proximity of pressure sensors to the surgical site during phacoemulsification surgery may allow for increased monitoring of, for example, the anterior chamber environment. Data collected from one or more of the sensors may allow for the development of an algorithm which may be used to monitor intraocular pressure, and predict occlusion and post occlusion surge events during surgery more accurately and in a more timely manner than is currently available. Using the developed algorithm, discussed herein below, the system may adjust the irrigation and/or aspiration rates in order to improve, for example, anterior chamber stability. Similarly, when the aspiration slows down, fluid circulation may recede and the heat generated from the handpiece tip may damage the eye's tissues, which is not desirable.

As illustrated in handpiece system <NUM> of <FIG>, at least one sensor module <NUM> may be placed in proximity to the phacoemulsification handpiece. Such a module may include a pressure sensor in communication with irrigation line <NUM> as well as a pressure sensor in communication with the aspiration line <NUM>. The sensor module <NUM> may receive power and transmit sensor measurement data over power and data pins located in the communication module <NUM> located on the handpiece <NUM>. The communication module <NUM> may operate on a specific voltage, for example, and may transmit measurements to the console and or system via a wireless or wired connection.

As illustrated in <FIG>, the module may receive power from the console or other aspect associated with the console through cable <NUM> and may similarly transmit data through cable <NUM>. The handpiece system <NUM> may transmit sensor and other data wirelessly through communication module <NUM> via any known wireless communication means to a desired portion of the surgical console or system (not shown), such as, for example, via a dedicated wireless method such as Bluetooth Low Energy (BLE), Near Field Communications (NFC) or Wi-Fi technologies.

Power to the phacoemulsification hand piece sensor module may be provided through a coin cell battery or like power source which may eliminate the need for cable <NUM>. In such an embodiment, the lack of cable <NUM> may require the use of wireless communications through communication module <NUM>, as discussed above, and may allow for a less cumbersome use of the handpiece <NUM>. In an embodiment, communication module <NUM> may be part of sensor module <NUM>.

A steady and inflated anterior eye chamber may allow the surgeon to perform a more successful phacoemulsification procedure for cataract lens extraction and IOL insertion than otherwise possible with a high variance of pressure in the anterior chamber of the patient's eye. The intraoperative pressure in the anterior chamber of the eye is a function of irrigation pressure, aspiration vacuum, and wound leakage. Variation of the anterior chamber pressure may come from the mismatch of sudden aspiration vacuum surge with unmet irrigation inflow, for example. The variation of the anterior chamber pressure causes instability and is not desirable during cataract lens extraction.

A typical method to provide a steady irrigation pressure is to hang a BSS container (e.g. bottle or bag) on an IV pole, or to pressurize the source BSS with additional pressure such as air or mechanical force, and connect the BSS via a tube to the irrigation port of the handpiece. The irrigation flow rate to the anterior chamber is then determined by the source pressure and the irrigation line resistance. The aspiration vacuum used may be generated by peristaltic pump or a Venturi vacuum source downstream from the handpiece aspiration port via a second tube. The aspiration vacuum level may be determined by the peristaltic vacuum setting, the Venturi vacuum setting, and/or one or more pressure or flow sensors. The aspiration vacuum may vary when operating in phacoemulsification mode when certain cataract material being removed from the anterior chamber partially or fully blocks the handpiece tip, also known as an occlusion event.

During an occlusion event, the vacuum continues to build up in the aspiration line, while the aspiration flow rate is reduced or stopped. Occasionally, the occlusion breaks free and the stored energy in the aspiration line is applied to the anterior chamber and suddenly pulls fluid from the anterior chamber resulting in a surge of outflow. When the irrigation inflow is substantially less than the aspiration out flow, the anterior chamber pressure will be less than steady state. More specifically, the anterior chamber pressure may be much lower than atmospheric pressure level, for example. Under such a condition, the anterior chamber may soften and become shallow, or in severe condition, may collapse.

Methods for maintaining intraoperative IOP may include pressurized infusion, occlusion and post occlusion surge detection, and IOP control. More specifically, the system may utilize in-line irrigation and aspiration pressure sensors, as discussed above, to provide a more accurate and real-time measurement of system pressures nearer the surgical site. Such measurements, along with foot pedal position and bottle height (or specific irrigation pressure, for example), may provide inputs into certain algorithms (discussed in more detail herein) for control of system fractions.

For example, the system may increase infusion pressure (irrigation) or reduce the aspiration flow and/or vacuum upon the detection of a post occlusion surge event. Each of these aforementioned elements may be used to improve intraoperative IOP management throughout surgery. For example, using a pressurized irrigation source may provide the capability of quickly increasing and/or decreasing irrigation pressure to maintain anterior chamber stability during post occlusion surge events, for example.

The intraoperative pressure management algorithms may incorporate at least some portion of measurable attributes associated with phacoemulsification surgery. Measurable attributes may include patient eye level and wound leakage calibration, intraocular pressure changes during aspiration outflow, occlusion and post occlusion surge detection and mitigation actions, balanced salt solution (BSS) usage, and irrigation and aspiration line block detection, for example.

One or more pressure sensors may be used within a surgical system and may provide data which may be used to control aspects of the surgical system. In an embodiment, a system level architecture and sensor placement of the present invention is illustrated in <FIG>. In system <NUM>, surgical console <NUM> may be in communication with irrigation source <NUM> and handpiece <NUM>, for example. Surgical console <NUM> may also be in communication with pump <NUM>, gas reservoir <NUM>, and pressure regulator <NUM>, each of which may be used for pressurized irrigation. Surgical console <NUM> may also be in communication with fluidics pack <NUM> and system controller <NUM>, which may additionally be in communication with an intranet/internet <NUM>.

Within system <NUM>, an irrigation (pressure or flow) sensor <NUM> may be located in close proximity to and/or be coupled with handpiece <NUM>. Similarly, aspiration (pressure, vacuum, or flow) sensor <NUM> may be located in close proximity to and/or be coupled with handpiece <NUM>. The aspiration sensor <NUM> or the irrigation sensor <NUM> may be used alone to provide substantially the same improvement in measurements. As described herein, the use of one or more sensors may provide improved real-time measurements of patient eye level and wound leakage.

As used herein, "patient eye level" is defined as the height difference between the patient's eye and the fluidics pack where irrigation and aspiration lines are terminated. This height difference may result in a certain amount of pressure inside the anterior chamber. As would be understood by those skilled in the art, a handpiece with the appropriate tip/sleeve and irrigation/aspiration lines would be inserted in the patient's eye through an incision in the anterior chamber. "Wound leakage", as used herein, is defined as the fluid out flow from the anterior chamber during surgery through the incision site. The amount of fluid out flow and related pressure changes inside the chamber may be a function of incision size.

The irrigation sensor <NUM> and aspiration sensor <NUM>, may each be located at the handpiece <NUM> and may be able to measure the pressure changes inside the anterior chamber due to patient eye level and wound leakage given close proximity of the sensors to the anterior chamber. In an embodiment of the present invention, during the prime/tune of surgical console <NUM>, the system <NUM> may perform an initial patient eye level calibration by storing pressure measurements taken by sensor <NUM> and sensor <NUM>. Similarly, subsequent measurements may be taken by sensor <NUM> and sensor <NUM> and stored when the handpiece <NUM> is inserted into the anterior chamber while there is no aspiration outflow.

As will be appreciated by those skilled in the art, intraoperative pressure may change inside the anterior chamber during aspiration outflow. In an embodiment of the present invention, a surgeon may program surgical console <NUM> to establish a desired intraoperative pressure prior to the start of surgery. When handpiece <NUM> is inserted into the anterior chamber of the eye <NUM>, the intraoperative pressure management algorithm may take one or more measurements from the irrigation sensor <NUM>, for example, and compare the obtained value to the desired pressure value contained in the console <NUM> and/or stored in system controller <NUM>. If, for example, the irrigation sensor <NUM> measurement is higher than the desired pressure, then the algorithm may reduce the irrigation pressure/flow by commanding the pressure regulator <NUM> to vent excess pressure until the irrigation pressure/flow is substantially equal to the desired pressure. If, for example, the irrigation pressure measurement is lower than the desired pressure/flow, then the algorithm may increase the irrigation pressure by commanding the pressure regulator <NUM> to increase pressure until the irrigation pressure/flow is substantially equal to the desired pressure.

As illustrated in <FIG>, the intraoperative pressure management algorithm, which may be resident in surgical console <NUM>, and, more particularly, within subsystem controller <NUM>, may receive sensor data from the analog to digital converter (ADS) <NUM>, and may continuously measure and adjust the irrigation pressure of system through the IOP management controller <NUM>, in order to maintain the anterior chamber pressure within certain intraoperative parameters. An exemplary ADS for use with system <NUM> is illustrated in <FIG>. By way of non-limiting example, the intraoperative pressure management algorithm may account for a drop in the anterior chamber pressure due to fluid outflow when the surgeon begins to aspirate fluid by pressing on a foot pedal controller (not shown). The IOP management controller <NUM> may control the pump <NUM>, a gas reservoir <NUM>, the pressure regulator <NUM>, and/or the height of irrigation source <NUM>.

In an embodiment of the present invention during peristaltic (flow) based aspiration, the intraoperative pressure management algorithm may obtain data related to the intraoperative pressure drop caused by the aspiration outflow from the console <NUM>. Such data may be stored as a lookup table or as linear/polynomial functions of commanded aspiration flow rates (as provided to the console through operation by a surgeon during a procedure) and may take the form as shown below:.

The intraoperative pressure management algorithm may adjust the irrigation pressure via the IOP management controller <NUM> based on the commanded aspiration flow rate and respective change in the intraoperative pressure. For example:
<MAT>.

As illustrated in the equation above, the Irrigation Pressure (t-<NUM>) would be equal to the desired pressure set initially prior to aspiration outflow. For a given commanded aspiration outflow, the algorithm may increase or decrease the irrigation pressure based on the commanded aspiration flow rate in order to keep the anterior chamber pressure within desired pressure range during the surgery.

In Venturi (vacuum) based aspirations, for example, the intraoperative pressure management algorithm may obtain the intraoperative pressure drop caused by the aspiration outflow from console <NUM>. This may be a lookup table or linear/polynomial function of actual Venturi vacuum measured by sensor <NUM> and represent respective changes in the intraoperative pressure inside the chamber as shown below:.

Similarly, the intraoperative pressure management algorithm may adjust the irrigation pressure to the handpiece <NUM> based on the measured Venturi vacuum and respective change in the intraoperative pressure.

The Irrigation Pressure (t-<NUM>) would be equal to desired pressure set initially prior to aspiration outflow. With the aspiration outflow, the algorithm would increase or decrease the irrigation pressure based on the measured Venturi vacuum in order to keep the anterior chamber pressure within the desired pressure range during the surgery. The intraoperative pressure management algorithm may also continue to monitor if the aspiration flow is increasing or decreasing or has become at least partially occluded and may adjust the irrigation pressure accordingly.

In an embodiment of the present invention, the intraoperative pressure management algorithm measures the difference between sensor <NUM> and sensor <NUM> along the aspiration fluid path to calculate actual aspiration flow rate in real-time. This method may be used for both Peristaltic and Venturi based aspiration. The fluid flow between two points of measurement along the aspiration line with a known radius and length may be directly related to pressure difference. Thus, an increase in fluid flow may result in a higher pressure difference between two points and vice versa. Similarly, if the aspiration line is fully or at least partially occluded the pressure difference between two points may approach zero. Using the Hagen-Poiseuille law of fluid dynamics:
<MAT>.

Wherein ΔP = Average (sensor <NUM>) - Average (sensor <NUM>); r = inner radius of the aspiration tubing; L= length of aspiration tubing from sensor <NUM> to sensor <NUM>; Q = flow rate of the fluid (i.e., water or BSS); and µ = viscosity of the fluid (i.e., water or BSS).

As previously described, the algorithm may use a lookup table or linear/polynomial function of actual or measured aspiration flow rate and respective change in the intraoperative pressure inside the chamber as shown below:.

The intraoperative pressure management algorithm may adjust the irrigation pressure based on the actual aspiration flow rate and respective change in the intraoperative pressure. Again:
<MAT>.

Where the Irrigation Pressure (t-<NUM>) would be equal to desired pressure set initially prior to aspiration outflow. With the aspiration outflow, the algorithm may increase or decrease the irrigation pressure based on the actual aspiration flow rate in order to keep the anterior chamber pressure within desired pressure range during the surgery.

In an embodiment of the present invention, the intraoperative pressure management algorithm measures the difference between the two sensors <NUM> and <NUM> along the aspiration fluid path to determine the change in intraoperative pressure due to the aspiration outflow. This method may be the same for both peristaltic and Venturi based aspiration. The fluid flow between two points of measurement along the line with certain radius and length is directly related to pressure difference. Thus, an increase in fluid flow may result in a higher pressure difference between two points and vice versa. When the aspiration line is partially to fully occluded (i.e., restricted to no fluid flow), the pressure difference between two points would approach zero. Again, the algorithm may rely on a lookup table or linear/polynomial function of aspiration pressure/vacuum difference and the respective change in the intraoperative pressure inside the chamber as shown below:.

The intraoperative pressure management algorithm may adjust the irrigation pressure based on the actual aspiration flow rate and respective change in the intraoperative pressure. Again, using:
<MAT>.

Where the Irrigation Pressure (t-<NUM>) would be equal to desired pressure set initially prior to aspiration outflow. With the aspiration outflow, the algorithm may increase or decrease the irrigation pressure based on the actual aspiration flow rate in order to keep the anterior chamber pressure within desired pressure range during the surgery. As discussed herein, the intraoperative pressure management algorithm may continue to monitor if the aspiration flow has increased or decreased or has become partially or fully occluded, and may adjust the irrigation pressure accordingly. Other inputs to the algorithm, such as foot pedal console control, such as transitioning between known positions of commands, may be used in combination with actual flow measurements to keep the anterior chamber pressure stable during the aspiration flow.

In an embodiment of the present invention, occlusion and post occlusion surge detection and mitigation may be obtained through the use of sensors (pressure, vacuum, and/or flow) proximate to the surgical site, preferably on the distal end of the handpiece. As discussed above, occlusion and post occlusion surge detection may be detected in both peristaltic and Venturi based aspiration. By way of example, during aspiration outflow, an occlusion may be created when the handpiece tip is blocked by small fragment of cataract particulate. The blocked tip may cause a vacuum to build in the aspiration line. If the occlusion breaks, the stored the stored energy in the tubing pulls fluid from the anterior chamber. The volume of fluid that the aspiration tubing pulls depends on how much the tubing deformed during the occlusion. This deformation in conjunction with the occlusion itself causes a post occlusion surge in the aspiration line and a drop in intraoperative pressure inside the anterior chamber of the patient's eye.

The algorithm uses the sensors <NUM> and <NUM> to detect tip occlusions and post occlusion surge by taking the difference in measurement between sensor <NUM> and <NUM>, e.g. using: <MAT>.

The algorithm may detect tip occlusions based on predetermined occlusion thresholds or a range of predetermined occlusion thresholds. In an embodiment, a range of predetermined occlusion thresholds may be, as a non-limiting example, <NUM>%, <NUM>%, <NUM>%, <NUM>%, and <NUM>%; whereas a single threshold may be, as a non-limiting example, <NUM>% or <NUM>%. In an embodiment, the algorithm may detect tip occlusions if, for example, the predetermined occlusion threshold of <NUM>% may be the difference between the measurements taken at sensor <NUM> and <NUM> as it approaches <NUM>% of the maximum set vacuum and the measurement at sensor <NUM> is greater than <NUM>% of maximum set vacuum in peristaltic and/or Venturi based aspiration. The sensor(s) may measure pressure, vacuum and/or flow, e.g. flow rate and the threshold(s) an/or maximum settings may be based on pressure, vacuum and/or flow.

In an embodiment, predetermined occlusion threshold of <NUM>% may be the difference between the measurement at sensor <NUM> and the measurement at sensor <NUM> as it approaches <NUM>% of the maximum set vacuum and the measurement at sensor <NUM> is greater than <NUM>% and less than <NUM>% of the maximum set vacuum in the peristaltic and/or Venturi based aspiration. Any values of the threshold(s) and maximum settings may be preset/preprogrammed or set by a user and/or may be set/programmed to achieve a desired functionality of the system.

Irrigation Pressure (t) would be set to desired intraoperative pressure established by a user of the phacoemulsification system earlier or prior to the start of surgery. The algorithm may then help detect post occlusion surge if the pressure surge is greater than predetermined post occlusion surge threshold in both peristaltic and/or Venturi based aspiration.

Irrigation Pressure (t) would be set based on the aspiration outflow established earlier or prior to the start of surgery.

Both Peristaltic and Venturi based aspiration system, using the intraoperative pressure management algorithm has the capability to at least partially mitigate the effects of post occlusion surge by providing the timely addition of infusion flow to compensate for fluid loss during a surge event. In <FIG>, the actual IOP measured is indicated by line <NUM>, the actual measured irrigation pressure is indicated line <NUM>, the actual measured aspiration vacuum is measured by line <NUM>, and the system generated flag indicative of an occlusion event is line <NUM>. As is illustrated in <FIG>, for example, a sudden and steep increase in the aspiration vacuum may be indicative of an occlusion event.

The present invention may use the algorithm discussed herewith to begin ramping up the irrigation pressure with determined slope when, for example, a tip occlusion has occurred and is detected. For example, irrigation pressure as measured by sensor <NUM>, in <FIG>, proximate to the distal end of the handpiece <NUM> may be close to column height of the fluid or specified infusion pressure after accounting for patient eye level and wound leakage in a continuous irrigation or irrigation only mode. During surgery, if an occlusion at the tip of the handpiece <NUM> occurs, aspiration flow may be stopped or slowed depending on the type of occlusion which may, in turn, cause the aspiration vacuum to reach maximum present vacuum and the irrigation flow to stop or slow and irrigation pressure to increase to column height of the fluid or specified infusion pressure. This information may allow the algorithm to detect an occlusion, which, when removed, may allow the aspiration flow to be restored to the preset maximum aspiration flow rate. This rapid change in aspiration flow may trigger a post occlusion surge event inside the anterior chamber of the eye and may lead to a quick decrease in irrigation pressure and a decrease in aspiration vacuum. Upon detection of a post occlusion surge event, the present invention may increase the infusion pressure in time to substantially make up for the lost fluid volume due to aspiration flow. This may reduce the effect of the post occlusion surge inside the anterior chamber and keep the chamber at equilibrium.

As illustrated in <FIG>, a peristaltic system may behave in a similar manner under the control of the present invention. The algorithm of the present invention may detect that an occlusion has occurred as indicated by the occlusion flag line <NUM> going low with the post occlusion surge event approaching as indicated by the occlusion flag line <NUM> going high. When aspiration vacuum <NUM> goes low, the present invention may begin to increase the infusion pressure with a certain slope and maintain the pressure at a certain level once it reaches an upper bound of about 100mmHg, for example. When the post occlusion surge event occurs, additional infusion pressure, illustrated by irrigation line <NUM>, may help to reduce the effect of a surge event, as illustrated by aspiration line <NUM>, as shown in the IOP line <NUM> staying above about 20mmHg. The increase in infusion pressure may be a function of aspiration vacuum such that a higher aspiration vacuum may lead to quicker infusion pressure build up.

The infusion pressure may be limited to a certain upper bound to ensure that pressure is within acceptable range - an upper bound which may be set by the user of the system. When the occlusion break occurs, the additional infusion flow may help to reduce the drop in the intraoperative pressure, thus providing greater anterior chamber stability.

As would be appreciated by those skilled in the art, the intraoperative pressure management algorithm may provide a capability to determine BSS usage during the surgery. The system may use a pump (e.g. a flow based (peristaltic) or vacuum based (Venturi) pump) to transfer fluid from the BSS container to the pressurized infusion tank inside the fluidics pack <NUM>, as illustrated in <FIG>. The system, via the console <NUM>, for example, may track the starting and ending encoder counts to determine the amount of fluid transferred to the tank. A running count may be accumulated throughout the surgery to provide real-time BSS usage. The BSS usage may be reset when the fluid pack <NUM> is ejected from the system.

The existence of an occlusion may be determined by the system by first measuring and storing values of system aspiration and irrigation to use as a benchmark against additional measurements taken during system use. Benchmarks which may be compared to real time system measurements and used with the IOP prediction algorithms discussed hereinabove. If an occlusion is detected, the system may utilize the post occlusion management algorithm and may continue to loop through until no occlusion and, thus, no post occlusion surge, is detected.

The system may also determine if either the irrigation and/or aspiration line has been disconnected to either the handpiece or surgical console. The intraoperative pressure management algorithm may be used to monitor each of the in-line sensors associated with the system and alert the user if, for example, open atmosphere pressure is detected.

Both irrigation and aspiration pressure sensors may be placed away from the handpiece. However, propagation delay caused by the tubing length and other characteristics would need to be added into the algorithm. Both irrigation and aspiration sensors may be placed inside the fluidics pack to measure the irrigation and/or aspiration pressure during surgery. In-line or non-contact flow sensors may be used to measure the irrigation and/or aspiration flow during surgery. The intraoperative pressure management algorithm may be modified to incorporate data associated with fluid flow changes during surgery.

In an embodiment of the present invention, at least two in-line aspiration pressure sensors are used to measure the pressure difference along the aspiration fluid path. A first sensor may reside inside the surgical console (e.g., a strain gauge vacuum) and a second sensor may be placed at the distal end of the handpiece on the aspiration luer connector, for example. These two sensors may measure the aspiration pressure/vacuum real-time during the surgery. The fluid flow between these two points of measurement along a tube having a certain radius and length is directly related to pressure difference. Thus, an increase in fluid flow would result in higher pressure difference between two points and vice versa. As discussed above, when the aspiration line is partially or fully occluded (i.e., near to no fluid flow), the pressure difference between the two sensors would approach zero. The use of the present invention may allow for real-time Venturi aspiration flow determination which may allow the flow to be adjusted as necessary to maintain a stable anterior chamber of the eye during surgery.

In an embodiment of the present invention, a mass air flow sensor may be placed in-line between the Venturi source/regulator and the Venturi output port on the fluid pack manifold. The Venturi fluid flow may be established based on the Venturi air flow changes detected by the mass air flow sensor.

As discussed above, maintaining anterior chamber pressure is of high value to both the patient and the surgeon alike. In an embodiment of the present invention, to maintain anterior chamber pressure in a near-steady state, or at least to keep the anterior pressure within a safe margin above atmospheric pressure, the aspiration flow rate may be limited by using a small inside diameter aspiration line and phacoemulsification tip, or to set the vacuum limit to a lower value. Similarly, the irrigation line flow capability may be increased by raising the irrigation pressure, or increasing the inside diameter of the irrigation line. However, over reducing the inside diameter of the aspiration line and the phacoemulsification tip may cause clogging during phacoemulsification, and may reduce the aspiration vacuum limit which may greatly impact the efficiency of the phacoemulsification procedure. Similarly, raising the IV pole height or otherwise increasing the irrigation pressure may effectively increase irrigation pressure, but such pressure increases may to too long to effectuate. For example, such methods raise pressure at best in a matter of <NUM>/<NUM> of a second, or seconds. Furthermore, increasing the inside diameter of the irrigation line may making priming more difficult.

As illustrated in <FIG>, the reduced pressure mechanism <NUM> may be located at any point along irrigation line <NUM> between the irrigation source <NUM> and the handpiece <NUM>. An in-line check valve (not shown) in series and between reduced pressure mechanism <NUM> and irrigation source <NUM> may ensure that pressured fluid moves towards the handpiece <NUM> and may also prevent fluid back flow from the anterior chamber toward the irrigation source <NUM> when the mechanism retracts from the activated position to deactivated position, for example. Reduced pressure mechanism <NUM> may be a single, unitary device, such as a direct action actuator which may exert pressure on the irrigation line <NUM> by using a plunger or other like apparatus to reduce the interior diameter of the irrigation line <NUM> sufficiently to force a quantity of irrigation fluid forward through the handpiece <NUM> into the eye <NUM>. As discussed above, sensors associated with the present invention may allow the surgical console <NUM> to track and monitor pressure changes associated with occlusions and may activate reduce pressure mechanism <NUM> as necessary to maintain a desired pressure in the eye <NUM>, and, more specifically, in the anterior chamber of eye <NUM>.

Reduced pressure mechanism <NUM> may also be composed of multiple parts. For example, reduced pressure mechanism <NUM> may include an actuation mechanism <NUM> and a compensation volume module <NUM>. The inclusion of a compensation volume module <NUM> may allow for an increased volume of irrigation fluid available to the reduced pressure mechanism <NUM>. For example, compensation volume module <NUM> may include additional amounts of irrigation line <NUM> which may be acted upon by actuation mechanism <NUM>. Such an increased amount of line may be accommodated by looping the line in a circular pattern and/or weaving the line in a serpentine manner. In any embodiment of line aggregation, those skilled in the art will recognize the various adaptations of actuators and plunger like formations may be made suitable to in part a desired force on at least a portion of the aggregated irrigation line. Similarly, compensation volume module <NUM> may include a reservoir of irrigation fluid which may be introduced into irrigation line <NUM> as necessary to create or augment an increase in pressure. The reduced pressure mechanism <NUM> and/or in-line check valve <NUM> may be incorporated into fluid pack <NUM>. Fluid pack <NUM> may be in the form of a cassette which may be removably attached to surgical console <NUM> and may include at least one reduced pressure mechanism <NUM> and/or at least one in-line check valve <NUM>.

The amount of momentary fluid pressure and the duration of time the applying time of the irrigation source may be adjusted by the reduced pressure mechanism <NUM> with the amount of pressure and time related to the compensation volume and the speed of the mechanism. As illustrated in <FIG>, the activation of reduced pressure mechanism <NUM> may lessen the drop in pressure experienced by a partial or full occlusion during phacoemulsification surgery. The graph illustrated in <FIG> shows a steep negative change in system pressure sans activation of reduced pressure mechanism <NUM> as illustrated by the dashed line. The solid line illustrated in <FIG> illustrates system pressure with activation of the reduced pressure mechanism <NUM>.

More specifically, the activation of the reduced pressure mechanism <NUM> may correspond to the detection of the occlusion event by the system and may be deactivated proximate to an indication that the irrigation pressure of the system is recovering. The increased pressure applied by the reduced pressure mechanism <NUM> significantly reduces the loss of pressure due to an occlusion event and, used alone, may not affect the increase in pressure that might be experienced by the system after compensation for the occlusion event. The use of the reduced pressure mechanism <NUM> may be included with other aspects of the system to improve the reduction in pressure loss and to mitigate any undesired pressure gain after compensation for an occlusion event. Similarly, reduced pressure mechanism <NUM> may also detect and compensate for loss of pressure associated with leaks and/or breaks in the fluid lines, e.g. irrigation and/or aspiration lines and may provide an alert or activate a safety feature if the loss of pressure, such as from a line failure, is too great for the system to correct.

Claim 1:
A system for detecting intraocular pressure events during phacoemulsification surgery, the system comprising:
a surgical console (<NUM>), having at least one system bus (<NUM>) communicatively connected to at least one computing processor capable of accessing at least one computing memory associated with the at least one computing processor;
an intraoperative pressure management algorithm;
a surgical handpiece (<NUM>) having a distal end and a proximal end, the proximal end being communicatively connected to at least one irrigation line (<NUM>) and at least one aspiration line (<NUM>);
a first pressure, vacuum or flow sensor (<NUM>) in communication with the at least one aspiration line (<NUM>) for providing a first measurement value; and
a second pressure, vacuum or flow sensor (<NUM>) in communication with the at least one aspiration line (<NUM>) for providing a second measurement value; and
wherein the intraoperative pressure management algorithm is configured to change the pressure of the irrigation fluid in the at least one irrigation line in accordance with the difference between the first measurement value and the second measurement value.