专利摘要:
pressure control in a phacoemulsification system. a surgical system comprises a source of pressurized irrigation fluid; an irrigation line fluidly coupled to the source of pressurized irrigation fluid; a handpiece 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 source of pressurized irrigation fluid. the controller controls the source of pressurized irrigation fluid based on a reading from the irrigation pressure sensor and an estimated flow value modified by an offset factor.
公开号:BR112015008307B1
申请号:R112015008307-2
申请日:2013-10-11
公开日:2021-06-01
发明作者:Raphael Gordon
申请人:Alcon Research, Llc;
IPC主号:
专利说明:

FUNDAMENTALS OF THE INVENTION
[001] The present invention relates to phacoemulsification surgery and, more particularly, to the control of fluid flow during surgery.
[002] The human eye works to provide vision by transmitting light through a transparent outer portion, called the cornea, and focusing the image through a crystalline lens onto a retina. The quality of the focused image depends on many factors, including the size and shape of the eye and the transparency of the cornea and lens. When age or disease causes the lens to become less transparent, vision deteriorates due to the diminished light that can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function with an artificial intraocular lens (intraocular lens).
[003] In the United States, most cataract lenses are removed by a surgical technique called phacoemulsification. A typical surgical instrument suitable for cataract lens phacoemulsification procedures includes a phacoemulsification ultrasound-actuated handpiece, an attached hollow cutting needle surrounded by an irrigation sleeve, and an electronic control console. The handpiece is connected to the control console by an electrical cable and flexible tubing. Through the electrical cable, the console varies the level of power transmitted by the handpiece to the attached cutting needle. Flexible tubing delivers irrigation fluid to the surgical site and draws aspiration fluid from the eye through the handpiece.
[004] During a phacoemulsification procedure, the tip of the cutting needle and the end of the irrigation glove are inserted into the anterior segment of the eye through a small incision in the outer tissue of the eye. The surgeon brings the tip of the cutting needle into contact with the lens of the eye so that the vibrating tip breaks up the lens. The resulting fragments are aspirated out of the eye through the interior hole of the cutting needle, along with the irrigation fluid supplied to the eye during the procedure, and into a waste reservoir.
[005] During the entire process, the irrigation fluid is infused into the eye, which passes between the irrigation glove and the cutting needle and out into the eye at the tip of the irrigation glove and/or one or more orifices or openings formed in the irrigation sleeve near its edge. This irrigation fluid is critical as it prevents the eye from collapsing during the removal of the emulsified lens. Irrigation fluid also protects eye tissues from the heat generated by the vibration of the ultrasonic cutting needle. In addition, the irrigation fluid suspends the emulsified lens fragments for aspiration from the eye.
[006] Conventional systems use liquid-filled bottles or pouches hanging from an intravenous (IV) bracket as a source of irrigation fluid. Irrigation rates and corresponding fluid pressure in the eye are regulated by controlling the height of the IV bracket above the surgical site. For example, raising IV support results in a corresponding increase in head pressure and an increase in fluid pressure in the eye, which results in a corresponding increase in irrigation flow rate. Likewise, the reduction in IV support results in a corresponding decrease in pressure in the eye and a corresponding flow rate of irrigation to the eye.
[007] Eye fluid aspiration flow rates are normally regulated by an aspiration pump. Pump action produces aspiration flow through the inner hole of the cutting needle. Suction flow results in the creation of a vacuum in the suction line. Aspiration flow and/or vacuum are adjusted to achieve the desired working effect for lens removal. The height of the IV bracket and irrigation pump are regulated to achieve proper balance in the intraocular chamber, in an effort to maintain relatively consistent fluid pressure at the surgical site within the eye.
[008] While consistent fluid pressure in the eye is desirable during the phacoemulsification procedure, a common phenomenon during a phacoemulsification procedure arises from the varied flow rates that occur throughout the surgical procedure. The varying flow rates result in different pressure losses in the passage of irrigation fluid from the irrigation fluid supply to the eye, thus causing changes in pressure in the anterior chamber (also called Intraocular Pressure or IOP). Higher rates result in higher pressure losses and lower IOP. As IOP goes down, the operating space inside the eye decreases.
[009] Another common complication during the phacoemulsification process arises from a blockage or occlusion of the aspiration needle. As the irrigation fluid and emulsified tissue are aspirated away from the interior of the eye through the hollow cutting needle, pieces of tissue that are larger than the diameter of the needle hole can become clogged at the tip of the needle. While the tip is clogged, vacuum pressure builds up inside the tip. The resulting drop in pressure in the anterior chamber of the eye when the obstruction is removed is known as the post-occlusion peak. This post-occlusion peak, in some cases, can cause a relatively large amount of fluid and tissue to be aspirated out of the eye very quickly, potentially causing the eye to collapse and/or causing the lens capsule to collapse. tear.
[010] Several techniques have been tried to reduce this peak, such as by ventilating the suction line or otherwise limiting the increase in negative pressure in the suction system. However, there remains a need to improve phacoemulsification devices, including irrigation systems that reduce post-occlusion peak, as well as maintain a stable IOP across different flow conditions. SUMMARY OF THE INVENTION
[011] In an embodiment consistent with the principles of the present invention, the present invention is a surgical system comprising a source of pressurized irrigation fluid; an irrigation line fluidly connected to the source of pressurized irrigation fluid; a handpiece fluidly connected 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 source of pressurized irrigation fluid. The controller controls the source of pressurized irrigation fluid based on a reading from the irrigation pressure sensor and an estimated flow value modified by an offset factor.
[012] The surgical system may also include a display and a controller input device. The controller input device can receive a desired intraocular pressure value and the controller can control the source of pressurized irrigation fluid to maintain the desired intraocular pressure value. The controller input device can receive a desired intraocular pressure range and the controller can control the source of pressurized irrigation fluid so as to maintain the desired intraocular pressure range. The controller can calculate an eye's intraocular pressure based on the reading of the irrigation pressure sensor, a source pressure sensor, or the aspiration pressure sensor, or from the estimated flow value modified by the compensation factor. The controller can also calculate the flow value calculated from the reading of the irrigation pressure sensor, the source pressure sensor, and an irrigation line impedance.
[013] The system may also include a suction line fluidly connected to the handpiece; a suction pressure sensor located on or along the suction line; and an aspiration pump configured to draw fluid through the aspiration line. In such a case, the controller can calculate the flow value calculated from the suction pressure sensor reading, a maximum vacuum pump achievable by the suction pump, and an impedance of the suction pump.
[014] The system can also include a flexible bag containing a fluid and two opposing plates. The flexible bag can be located between the two opposite plates. In such a case, the controller can calculate the estimated value based on the displacement or movement of the two opposite plates.
[015] In some embodiments, the compensation factor may be based on incision leakage and/or glove compression, a needle and glove selected by a procedure, or flow characteristics of the combination of needle and glove. The controller input device can receive needle and glove information and the controller uses the needle and glove information to select or calculate the compensation factor. The controller input device can receive the compensation factor as a user input.
[016] The controller can use a reading from the aspiration pressure sensor to determine if an occlusion is present or an occlusion break occurs. In such a case, the controller can control the source of pressurized irrigation fluid to accommodate changes in fluid flow that result from occlusion or occlusion breakage. The controller can use a reading from the irrigation pressure sensor to determine if an occlusion is present or if an occlusion break occurs. In such a case, the controller can control the source of pressurized irrigation fluid to accommodate changes in fluid flow that result from occlusion or occlusion breakage.
[017] In other embodiments of the present invention, a surgical system comprising: a pressurized irrigation fluid source, the pressurized irrigation fluid source comprising a flexible bag located between two opposing plates, the flexible bag containing a fluid; a position sensor located on or on one of the two opposing plates, the position sensor for determining the distance between the two opposing plates; an actuator for moving at least one of the two opposing plates so as to tighten the flexible pocket; and a controller for controlling the relative movement of the opposing plates. The controller receives the reading from the position sensor, determines the distance between the plates, and provides an estimate of the amount of fluid in the flexible bag.
[018] In other embodiments of the present invention, a surgical system comprising: a pressurized irrigation fluid source, the pressurized irrigation fluid source comprising a flexible bag located between two opposing plates, the flexible bag containing a fluid, a hinged plate located on a surface of one of the two opposing plates; a source pressure sensor located between a face of the hinged plate and a face of one of the two opposing plates, such that the face of the hinged plate presses the source pressure sensor against the face of one of the two opposing plates.
[019] It is to be understood that both the above general description and the following detailed description are exemplary and explanatory only and are intended to provide a further explanation of the invention as claimed. The following description, as well as the practice of the invention, sets out and suggests additional advantages and purposes of the invention.
[020] In an embodiment consistent with the principles of the present invention, a method of controlling a surgical system that has a fluid flow path comprises: receiving a pressure reading from an irrigation pressure sensor located along the fluid flow path; calculate an estimated fluid flow through the surgical system; modify the estimated fluid flow with a compensation factor; and controlling a source of pressurized irrigation fluid based on the pressure reading and the estimated fluid flow as modified by the offset factor.
[021] In other embodiments of the present invention, the method may also comprise one or more of the following: receiving a desired intraocular pressure value; and controlling the source of pressurized irrigation fluid so as to maintain the desired intraocular pressure value; receiving a desired intraocular pressure range; and controlling the source of pressurized irrigation fluid so as to maintain the desired intraocular pressure range; calculate an intraocular pressure of an eye based on the reading of the irrigation pressure sensor; calculate an intraocular pressure of an eye based on the estimated flow value modified by the compensation factor; receiving a reading from an aspiration pressure sensor located along the fluid path, a vacuum pump maximum achievable by the aspiration pump, and an aspiration pump impedance; and estimate the flow based on the difference between the suction pressure sensor reading and the maximum pump vacuum achievable by the suction pump; receiving a reading from the irrigation pressure sensor, a reading from a source pressure sensor, and an impedance of the fluid flow path between the source pressure sensor and the irrigation pressure sensor; and estimate flow based on the difference between the irrigation pressure sensor reading and the source pressure sensor; receive a compensation factor from a user; receive needle and glove information; and use the needle and glove information to select or calculate the compensation factor; receiving a pressure reading from an aspiration pressure sensor located along the fluid path; and using the pressure reading from the aspiration pressure sensor to determine if an occlusion is present or an occlusion break occurs; accommodate changes in fluid flow that result from occlusion or occlusion breakage; receive a pressure reading from the irrigation pressure sensor; and using the pressure reading from the irrigation pressure sensor to determine if an occlusion is present or an occlusion break occurs.
[022] In other embodiments consistent with the principles of the present invention, a method for calculating incision leakage comprises: calculating irrigation fluid flow; calculate aspiration fluid flow; and subtracting the calculated aspiration fluid flow from the calculated irrigation fluid flow; wherein the calculated irrigation fluid flow and the calculated aspiration fluid flow are determined from differential pressure measurements. BRIEF DESCRIPTION OF THE DRAWINGS
[023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention.
[024] Figure 1 is a diagram of the components in the fluid path of a phacoemulsification system that includes a pressurized irrigation source, in accordance with the principles of the present invention.
[025] Figure 2 is a source of pressurized irrigation fluid, according to the principles of the present invention.
[026] Figures 3 and 4 show a hinged pressure sensor arrangement for a pressurized irrigation fluid source, in accordance with the principles of the present invention.
[027] Figure 5 is a diagram of the system components in a pressurized irrigation fluid source control system. DETAILED DESCRIPTION OF THE PREFERRED MODALITIES
[028] Reference is now made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts.
[029] Figure 1 is a diagram of the components in the fluid path of a phacoemulsification system that includes a pressurized irrigation source, in accordance with the principles of the present invention. Figure 1 depicts the fluid path through eye 1145 during cataract surgery. Components include a source of pressurized irrigation fluid 1105, a source pressure sensor 1110, an irrigation pressure sensor 1130, a three-way valve 1135, an irrigation line 1140, a handpiece 1150, an irrigation line. aspiration 1155, an aspiration pressure sensor 1160, a vent valve 1165, a pump 1170, a reservoir 1175, and a drain bag 1180. Irrigation line 1140 provides irrigation fluid to eye 1145 during cataract surgery. The 1155 Aspiration Line removes fluid and emulsified lens particles from the eye during cataract surgery.
[030] When the irrigation fluid leaves the pressurized irrigation fluid source 1105, it travels through the irrigation line 1140 and into the eye 1145. An irrigation pressure sensor 1130 measures the pressure of the irrigation fluid in the irrigation line. 1140 irrigation. The 1130 irrigation pressure sensor can be located anywhere along the 1140 irrigation line or irrigation fluid path. If located near eye 1145, the irrigation pressure sensor may also be incorporated into the irrigation path of a handpiece 1150. In some cases, the irrigation line 1140 may pass through and include a path in a fluid cassette. In this case, the irrigation pressure sensor 1130 can be located in the fluid cassette. For purposes of this description, irrigation line 1140 may comprise flexible tubing, a path through a fluid cassette, rigid tubing, or other fluidic paths that transport irrigation fluid from pressurized irrigation fluid source 1105 through the handpiece. 1150 and eye 1145. Source pressure sensor 1110 also measures irrigation fluid pressure at the pressurized irrigation fluid source 1105. A three-way valve 1135 is provided to turn on/off irrigation control and to provide a path to drain bag 1180. Irrigation pressure sensor 1130 and source pressure sensor 1110 are implemented by any of a number of commercially available fluid pressure sensors. Irrigation pressure sensor 1130 and/or source pressure sensor 1110 provide information to a pressure controller (shown in Figure 5) that operates the source of pressurized irrigation fluid 1105. Pressurized irrigation source fluid 1105 controls the pressure and/or the flow of irrigation fluid leaving it.
[031] In some embodiments of the present invention, the pressurized irrigation fluid source 1105 includes a flexible bag that contains the irrigation fluid. In this case, the bag can be compressed to pressurize the fluid it contains. For example, the pouch can be located between two opposing plates that press together to pressurize the pouch's contents (as more fully described in Figure 2). In another example, a flexible band surrounds the pouch and is tightened to squeeze the pouch and pressurize its contents. In other embodiments of the present invention, the pressurized irrigation fluid source 1105 includes a bottle or other container that can be pressurized. In accordance with other embodiments of the present invention, the pressurized irrigation fluid source 1105 is pressurized using a pump or a compressed gas.
[032] The source 1110 pressure sensor can be a single pressure sensor or an array of pressure sensors. The source pressure sensor 1110 can contact the pressurized irrigation fluid source 1105 to determine the pressure of its contents. For example, when the pressurized irrigation fluid source 1105 is a flexible bag located between two opposing plates, the source 1110 pressure sensor may be located on one of the plates adjacent to the bag. As the plates move, the bag is pressurized and the pressure sensor and source 1110 measures the pressure. In this case, the source 1110 pressure sensor can be an array of sensors located on the board or a single sensor located on the board. In another example, a hinged plate can be used as described in more detail in Figure 4.
[033] Figure 2 represents the source of pressurized irrigation fluid 1105 as a flexible bag 1109 (eg an IV bag) located between two opposing plates 1106 and 1107. One of the two plates 1106 or 1107 can be fixed, while the other plate moves to compress or squeeze a flexible bag 1109. For example, a plate 1106 can be fixed and the plates 1107 can move to compress a flexible bag 1109. In Figure 3, a plate 1106 has an array of sensors. source 1110 pressure sensors located on a surface facing flexible bag 1109. In this way, reading each of the four source 1110 pressure sensors shown can lead to a more accurate pressure reading. In this example, the reading can be taken from each of the four source pressure sensors 1110, and the weighted readings or an errant reading eliminated. In Figure 4, a source 1110 pressure sensor (or an array of sensors) is located on plate 1106 under a hinge plate 1108. The flat surface of the hinge plate a pressure sensor 1108 contacts the source 1110. In some cases, the surface of flexible bag 1109 may wrinkle or crease when it is squeezed between plates 1106 and 1107. These creases or creases can lead to inaccurate pressure readings if a crease or crease is located in a pressure sensor of source 1110. an array of sensors as shown in Figure 3 is one way to overcome this problem. Using an 1108 hinged plate is another way. When using an 1108 hinged plate, a uniform flat surface always contacts the 1110 source pressure sensor.
[034] Figure 5 is a block diagram that represents some of the components of a phacoemulsification device. Figure 5 shows an irrigation line 1140, an irrigation pressure sensor 1130 at, along, or associated with irrigation line 1140, an aspiration line 1155, an aspiration pressure sensor 1160 at, along, or associated with aspiration line 1155, a handpiece 1150, a controller 1230, a flow command input device 1210 (e.g., a foot pedal), a display 1220, and an associated controller input device 1240 for inputting data or commands for system programming.
[035] Irrigation line 1140 extends between a source of pressurized irrigation fluid 1105 and handpiece 1150 and carries a fluid to handpiece 1150 to irrigate an eye during a surgical procedure (as shown in Figure 1 ). In one example, the fluid is a sterile saline fluid, however, other fluids may be used. At least a portion of irrigation line 1140 can be formed of a flexible tube, and in some embodiments, path 1140 is formed of multiple segments, with some segments being rigid and others being flexible.
[036] The 1130 irrigation pressure sensor is associated with the 1140 irrigation line and performs the irrigation pressure measurement function on the 1140 irrigation tube. In some embodiments, the 1130 sensor is a pressure sensor configured to detect conditions pressure currents. Sensor 1130 communicates signals indicative of detected pressure to controller 1230. Once received, controller 1230 processes the received signals to determine whether the measured pressure is above or below a desired pressure or within a preset desired pressure range. Although it has been described as a pressure sensor, the irrigation pressure sensor 1130 can be another type of sensor, such as a flow sensor that detects actual fluid flow and can include additional sensors to monitor additional parameters. In some embodiments, sensor 1130 includes its own processing function and the processed data is then communicated to controller 1230.
[037] Suction line 1155 extends from the handpiece to drain pan 1180 (as shown in Figure 1). The 1155 suction line carries fluid used to wash the eye as well as all emulsified particles.
[038] Suction pressure sensor 1160 is associated with suction line 1155 and performs the function of measuring the pressure of waste fluid in suction line 1155. Like sensor 1130 described above, sensor 1160 can be a sensor set to detect current pressure conditions. It communicates signals indicative of the detected pressure to the 1230 controller. The 1160 sensor, like the 1130 sensor, can be any suitable type of sensor, such as a flow sensor that detects actual fluid flow and can include additional sensors for monitoring fluid. additional parameters.
[039] The 1145 handpiece may be an ultrasonic handpiece that transports the irrigation fluid to the surgical site. The handpiece is configured as known in the art, to receive and operate with different needles or equipment depending on the application and procedure to be performed. It should be noted that, although an ultrasonic handpiece is discussed, the principles of the invention are intended to cover the use of vitrectomy cutter handpieces or other handpieces known in the art. For ease of reference, this application will refer to handpiece 1145 only, recognizing that the system operates similarly with other handpieces.
[040] In the example shown, the fluid control input device 1210 is typically a foot pedal. This can receive inputs indicative of a desired flow rate, desired pressure, or other characteristic of the fluid. This is configured to control the machine's operational configuration through a plurality of main control settings, including control of irrigation rate or pressure within each of the main control settings. In some embodiments, the command flow input device is not a foot pedal but is another input device located elsewhere on the machine.
[041] The 1240 controller input device allows a user to enter data or commands that affect system programming. In this embodiment, the input device of controller 1240 is associated with monitor 1220. However, it may be directly associated with the controller in a manner known in the art. For example, in some embodiments, the input device of a controller 1240 is a standard computer keyboard, a standard pointing device such as a mouse or trackball, a touch screen, or other input device.
[042] As is evident from Figure 5, the controller 1230 communicates with the monitor 1220, the flow command input device 1210, the handpiece 1150, the irrigation pressure sensor 1130, the flow sensor. suction pressure 1160, and controller input device 1240. It is configured or programmed to control the pressurized irrigation system based on preset programs or sequences.
[043] In use, the 1230 controller is configured to receive signals from the 1130 irrigation pressure sensor and process the signals to determine if the detected irrigation pressure is outside an acceptable range or above or below acceptable limits. If the 1230 controller detects unacceptable irrigation pressure, it controls the pressurized irrigation system to correct the pressure to a desired range. Likewise, in another example, controller 1230 is configured to receive signals from suction pressure sensor 1160 and process the signals to determine if the detected pressure is outside an acceptable range or above or below acceptable limits. If the 1230 controller detects an unacceptable pressure, it controls the pressurized irrigation system to correct the pressure to a desired range. In this way, the irrigation pressure sensor 1130 and/or the aspiration pressure sensor 1160 can be used to control the fluid pressure in the eye (IOP).
[044] Returning to Figure 1, a suction pressure sensor 160 measures pressure in suction line 1155 or suction path. 1160 Suction Pressure Sensor can be located anywhere along the 1155 suction line or suction path. If located near eye 1145, aspiration pressure sensor may be located in handpiece 1150. Aspiration pressure sensor 1160 is implemented by any of a number of commercially available fluid pressure sensors. Suction Pressure Sensor 1160 provides information to a pressure controller (shown in Figure 5) that operates the source of pressurized irrigation fluid 1105.
[045] A handpiece 1150 is placed in eye 1145 during a phacoemulsification procedure. Handpiece 1150 has a hollow needle that is ultrasonically vibrated in the eye to break the diseased lens. A sleeve located around the needle delivers irrigation fluid from an irrigation line 1140. The irrigation fluid passes through the space between the outside of the needle and the inside of the sleeve. Fluid and lens particles are aspirated through the hollow needle. In this way, the interior passage of the hollow needle is fluidly coupled to aspiration line 1155. Pump 1170 withdraws the aspirated fluid from eye 1145. An aspiration pressure sensor 1160 measures the pressure in the aspiration line. An optional vent valve can be used to vent the vacuum created by the 1170 pump. The aspirated fluid passes through a reservoir 1175 and a drain bag 1180.
[046] During a phacoemulsification procedure, the needle tip of a 1150 handpiece may become occluded with a lens particle. This creates a condition that is called an occlusion. During an occlusion, less fluid is generally aspirated from the eye, and the vacuum pressure in aspiration line 1155 increases as a result of the occlusion. Thus, during an occlusion, aspiration pressure sensor 1160 detects the increase in vacuum that is present in aspiration line 1155. When the occlusion breaks (ie, when the lens particle causing the occlusion is split by the ultrasound needle ), a spike occurs. The increase in vacuum in the 1155 aspiration line creates a sudden demand for fluid from the eye, resulting in a rapid reduction in IOP and reduced room for maneuver within the eye. This can lead to a dangerous situation where various structures in the eye can be damaged.
[047] After the occlusion breaks, the 1160 aspiration pressure sensor detects a pressure drop in the 1155 aspiration line. Likewise, the 1130 irrigation pressure sensor also detects the pressure drop in the 1140 irrigation line that occurs as a result of the occlusion break. Signals from irrigation pressure sensor 1130 and/or aspiration pressure sensor 1160 can be used by controller 1230 to control irrigation source 1105 as more fully described below.
[048] The pressurized irrigation system of the present invention is able to respond to spikes caused by occlusion disruption by increasing the irrigation pressure in irrigation line 1140. When an occlusion breaks and a spike occurs, irrigation fluid source Pressurized 1105 increases irrigation fluid pressure in response. Increasing the irrigation pressure of 1105 Pressurized Irrigation Fluid Source meets the added fluid demand caused by occlusion breakage. In this way, the pressure and resulting operating space in eye 1145 can be kept at a relatively constant value, which can be selected by the surgeon.
[049] Likewise, when an occlusion occurs, the irrigation pressure may increase as the fluid aspirated from the eye decreases. An irrigation fluid pressure increase detected by the irrigation pressure sensor 1130 can be used to control the pressurized irrigation fluid source 1105 to regulate the pressure in the eye 1145, i.e. to maintain the pressure in the eye 1145 within a range acceptable. In such a case, aspiration pressure sensor 1160 can also detect the presence of an occlusion and a reading from this can be used by controller 1230 to control a pressurized irrigation source 1105. 1105 pressurized irrigation is not increased but remains the same or decreases.
[050] Generally, control of the 1105 pressurized irrigation fluid source is based on two parameters: (1) a pressure reading and (2) an estimate of the irrigation flow based on the flow through the system (or a measurement of real rate through the system). The pressure reading can be from the irrigation pressure sensor 1130 (ie the pressure in the irrigation line), the aspiration pressure sensor 1160 (ie the pressure in the aspiration line) or the pressure sensor of source 1110 (ie, pressure at the pressurized irrigation source).
[051] In an embodiment of the present invention, control of the pressurized irrigation fluid source 1105 may be based on the irrigation pressure and flow through the system as modified by the offset factor (as described in detail below). Irrigation pressure can be used to control occlusion breakage and to maintain a constant intraocular pressure. Irrigation flow also determines IOP. Flow through the system as modified by the offset factor (which equates to flow irrigation) can be used to control incision leakage and glove compression. Collectively, these parameters can be used to maintain a constant intraocular pressure throughout the process.
[052] Estimated flow through the system is generally the fluid flow from pressurized irrigation source 1105 through irrigation line 1140, through handpiece 1150, into eye 1145, out of eye 1145, through handpiece 1150, through aspiration line 1155 and into drain bag 1180. In operation, fluid may also be lost from the system by leakage from eye 1145 or the wound through which the needle of handpiece 1150 is inserted (also called “incision leak”). Thus, the total fluid flow in the system is equal to the fluid flowing through the eye minus the fluid that is lost due to incision leakage.
[053] Fluid flow can be estimated based on a number of different calculations. For example, flow can be estimated by any of the following: (1) A differential pressure measurement to calculate flow can be based on a sensor reading of suction pressure plus pump impedance plus maximum vacuum reached by the suction pump . Flow can be calculated by the difference between the suction pressure measured on the suction pressure sensor 1160, the maximum vacuum that can be created by an 1170 pump, and the pump impedance. The impedance of the 1170 pump is a known parameter and the maximum vacuum that the pump creates can be accurately measured as well as the suction pressure (by suction pressure sensor 1160). In this way, the flow is estimated by the difference of two pressures in the fluid path and the impedance of that path. In this case, the two pressures are the pressure measured by the suction pressure sensor 1160 and the maximum pressure achievable by the pump 1170. The impedance in the present example is the impedance of the pump 1170. (2) The measurement of differential pressure to calculate flow can be based on the pressure source measured at the source pressure sensor 1110, the irrigation pressure measured at the irrigation pressure sensor 1130, and the impedance of the irrigation line (or irrigation path) from the irrigation source 1105 to an irrigation pressure sensor 1130. Flow can be calculated by the pressure difference between the irrigation source 1105 and the irrigation pressure sensor 1130 and an impedance of the irrigation line 1140 between the irrigation source and the pressure sensor of irrigation. In this way, the flow is estimated by the difference of two pressures in the fluid path and the impedance of that path. (3) When the pressurized irrigation fluid source 1105 is a flexible bag 1109 located between two opposing plates 1106 and 1107 (as shown in Figure 2), the movement of plates 1106 and 1107 corresponds to the flow of fluid through the system. The fluid flow and/or fluid volume used during the procedure can be estimated from the position of plates 1106 and 1107. In general, during the procedure, plates 1106 and 1107 move against each other to squeeze the liquid out of the flexible bag 1109 at a desired pressure or rate. The total fluid exiting flexible bag 1109 is directly related to the position of opposing plates 1106 and 1107. The closer the plates 1106 and 1107 are, the more fluid exits flexible bladder 1109. In this mode, the position of plates 1106 and 1107 it can also be used to indicate the amount of fluid remaining within the flexible bag 1109 and provides an indication to the surgeon of the fluid level in the flexible bag 1109 (e.g., displaying the fluid level on the 1220 monitor).
[054] Actual fluid flow through the system can also be affected by two different factors: incision leakage and glove compression. As noted above, handpiece 1150 has a sleeve located around a needle. The glove delivers the irrigation fluid from an irrigation line 1140 to the eye 1145. The irrigation fluid passes through the space between the outside of the needle and the interior of the glove. Fluid and lens particles are aspirated through the hollow needle. During the procedure, the glove and needle are inserted into the eye through a small incision. In this way, the glove comes into contact with the ocular tissue of the incision (or wound). Incision leakage describes the amount of fluid that leaves the eye through the wound (or through the space between the glove and the eye tissue, through which the wound is formed). During the procedure, fluid may exit the eye through the wound - such fluid loss exits the system (ie, the fluid exiting the eye does not pass through suction line 1155). Incision leakage usually results in the loss of a small amount of fluid, thus decreasing the total flow through the system. Mathematically expressed, irrigation flow = aspiration flow + incision leakage.
[055] Glove compression generally describes the condition where the glove is compressed or compressed against the needle when inserted into the incision. Glove compression occurs more often with smaller incisions and may or may not result in less incision leakage. Sleeve compression can restrict fluid flow through the system. Since compressing the sleeve increases the flow resistance in the system, the flow can be decreased when sleeve compression is present.
[056] Generally, losses due to incision leaks and glove compression are dependent on the type of needle and glove being used, as well as the surgeon's technique. Flow profiles for the various combinations of needles and gloves can be determined experimentally and the resulting data incorporated into an algorithm or database for use in controlling the source of pressurized irrigation fluid 1105. Alternatively, this experimental data can be aggregated for provide a range of different compensation factors (as described in the next paragraph). Surgeon technique differs considerably among the population of ophthalmologists. During the procedure, some surgeons may move the needle in a way that creates more compression in the glove. Surgeons also prefer different sizes of needles and gloves, as well as different incision sizes. These surgeon-specific factors also impact incision leakage and glove compression.
[057] A compensation factor can be implemented to compensate for these two different variables that result in a decrease in flow through the system: incision leakage and glove compression. Incision leak can be compensated with an estimated incision leak rate factor (which can be implemented as an offset that is defined as a default value). Sleeve compression can be compensated for with an estimated compression factor. The incision leak rate factor and the glove compression factor can collectively comprise the compensation factor. The compensation factor can be adjusted by the surgeon. The offset factor can be an offset that acts to increase or decrease the pressure in the pressurized irrigation fluid source 1105. For example, the offset factor can be an integer from zero to seven (zero being no offset and seven being maximum offset ).
[058] Irrigation flow can be estimated from the estimated flow through the system and the compensation factor. Since irrigation flow generally equals aspiration flow plus incision leakage. Therefore, the irrigation pressure can be estimated from the compensation factor and the estimated flow through the system.
[059] Generally, in order to compensate for the decrease in flow (or losses) resulting from incision leakage and glove compression, the pressure at the source of the 1105 pressurized irrigation fluid is found to be slightly increased. Such pressure increase can be implemented in an algorithm based on the compensation factor. In the example above, the surgeon can select a compensation factor of three to provide moderate compensation for incision leakage and glove compression. In this example, a compensation factor setting of three can correspond to a slight increase in pressure at the 1105 pressurized irrigation fluid source. In other words, the baseline pressure at the 1105 pressurized irrigation fluid source is increased slightly to compensate for these factors.
[060] In another example, the compensation factor can be implemented by a standard deviation value, which can be adjusted by the surgeon. A nominal constant can be the default offset value in the algorithm. The surgeon can adjust this default value by a factor (between zero for no compensation and 2 for double compensation). The standard displacement value can be determined by experimental data relating to the flow characteristics of the various combinations of needles and gloves. Some needle and glove combinations are much more common than others, so the most common combinations can be used to determine the standard deviation value. In other cases, a data aggregation can be used to determine the standard deviation value.
[061] In another example, the surgeon can enter the glove and needle type through the input device of the controller 1240. A barcode reader can be employed to scan the barcode of the surgical package, which includes the glove and needle. When controller 1230 receives the needle and glove information, it can determine the flow characteristics associated with the needle and glove (or retrieve the flow characteristics from a database) and select an appropriate compensation factor. In addition, physician preferences and/or data from previous procedures can be used to select the appropriate compensation factor. For example, parametric data from previous procedures can be used to determine the clinician's technique and adjust, modify, or select the compensation factor.
[062] Regardless of how the compensation factor is determined, the compensation factor can be used to compensate for flow losses. The compensation factor can be used to control the pressurized irrigation fluid source 1105 to provide an amount of fluid equal to the fluid lost due to incision leaks. The compensation factor can be used to control the pressurized irrigation fluid source 1105 to provide a slight increase in pressure to overcome the increase in flow resistance caused by glove compression. Furthermore, since the irrigation flow determines the IOP, the compensation factor is used to adjust the IOP as well as to compensate for flow losses.
[063] Therefore, control of the 1105 pressurized irrigation fluid source can be based on the irrigation pressure and flow through the system as modified by the offset factor. Irrigation pressure can be used to control occlusion breakage and to maintain a relatively constant IOP. Flow through the system, as modified by the compensation factor, can be used to compensate for incision leakage and glove compression and maintain a relatively constant IOP. Collectively, these parameters can be used to maintain a relatively constant IOP throughout the process.
[064] The IOP estimate can be based on the irrigation pressure sensor. The pressure drop between the irrigation pressure sensor and the eye is known because the characteristics of the passage between the irrigation pressure sensor and the eye are known. For example, if the irrigation pressure sensor is located in a fluid cassette that is connected to the handpiece 1150 through a length of an irrigation line 1140, then the flow impedance of the length of an irrigation line 1140 is a Irrigation route through hand part 1150 are both known (or can be measured). IOP can then be determined from the irrigation pressure sensor reading. The IOP reading can also be affected by glove compression (because the glove is in the irrigation path between the irrigation pressure sensor and the eye) and incision leakage. The compensation factor can be used to adjust the IOP for these losses (or changes in impedance).
[065] In an embodiment of the present invention, a surgeon selects a desired IOP. The source of pressurized irrigation fluid 1105 is then controlled to maintain the desired intraocular pressure. Since the IOP is based on a reading from the irrigation pressure sensor, the 1130 irrigation pressure sensor can be used to control the 1105 pressurized irrigation fluid source. In conjunction with the irrigation pressure, the flow through the system, as modified by the offset factor, can also be used to control the 1105 pressurized irrigation fluid source. The irrigation flow also determines IOP. The flow through the system, as modified by the offset factor, equals the irrigation flow. When an occlusion is present (as detected by the 1130 irrigation pressure sensor or the 1160 aspiration pressure sensor), the IOP can be maintained by this control scheme. Upon breaking the occlusion (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), the pressurized irrigation fluid source 1105 can be controlled to maintain a relatively constant IOP.
[066] Alternatively, source pressure sensor 1110 or suction pressure sensor 1160 can be used in place of an irrigation pressure sensor 1130 in the control scheme above.
[067] The control of the 1105 pressurized irrigation fluid source can also be described in three different states: steady state (when the needle is not clogged and the flow through the system is relatively constant); occluded state (when the needle is occluded and there is little or no flow through the system); and breakage or peak occlusion (when there is sudden and rapid flow through the system). An example from each state is described.
[068] For example, in steady state, the pressurized irrigation fluid source 1105 is controlled to maintain a selected IOP. The 1130 irrigation pressure sensor is used to provide an estimate of the IOP. A pressure reading from the 1130 irrigation pressure sensor is received by the 1230 controller. The desired IOP is also received by the 1230 controller. The controller directs the operation of the pressurized irrigation fluid source 1105 so as to maintain the desired IOP . In steady state, the controller typically directs the pressurized irrigation fluid source 1105 to deliver a fluid at a relatively constant pressure to maintain the IOP. In addition, the controller calculates an estimated value for fluid flow as modified by the compensation factor. In this example, at steady state, the flow can be estimated by a differential pressure measurement or by plate travel. In the case of a differential pressure measurement, the 1230 controller receives the pressure readings necessary for the differential pressure measurement and makes the calculation. In the case of plate path, controller 1230 receives readings from position sensors or the like and determines plate path. The compensation factor is also received by the controller (as input by the surgeon, for example). Since the irrigation fluid flow (estimated flow through the system as modified by the offset factor) is related to the IOP, the controller 1230 directs the operation of the pressurized irrigation fluid source 1105 to maintain a flow rate consistent with the desired IOP. The net result is that the compensation factor is used to adjust the fluid pressure for the pressurized irrigation fluid source 1105 to compensate for flow losses.
[069] When an occlusion occurs, the needle tip is totally or partially occluded with a lens particle. In the occluded state, flow through the system is reduced. The 1130 irrigation pressure sensor provides an estimate of the IOP. A pressure reading from the 1130 irrigation pressure sensor is received by the 1230 controller. The desired IOP is also received by the 1230 controller. The controller directs the operation of the pressurized irrigation fluid source 1105 so as to maintain the desired IOP . In an occluded state, the controller typically directs the pressurized irrigation fluid source 1105 to deliver a fluid at a relatively constant pressure to maintain the IOP. Maintaining pressure in an occluded state is likely to mean that plates 1106 and 1107 maintain flexible bag 1109 at relatively constant pressure. In addition, the controller calculates an estimated value for fluid flow as modified by the compensation factor as detailed above. Since the irrigation fluid flow (estimated flow through the system, as modified by the offset factor) is related to the IOP, the controller 1230 directs the operation of the pressurized irrigation fluid source 1105 to maintain a consistent flow rate. with the desired IOP. The net result is that the compensation factor is used to adjust the fluid pressure for the pressurized irrigation fluid source 1105 to compensate for flow losses (eg, incision leakage).
[070] When an occlusion break occurs, the lens particle at the tip of the needle is displaced and a fluid spike exists in the eye through the lumen of the needle. During occlusion breakage, flow through the system is increased. The 1130 irrigation pressure sensor provides an estimate of the IOP. A pressure reading from the 1130 irrigation pressure sensor is received by the 1230 controller. The desired IOP is also received by the 1230 controller. The controller directs the operation of the pressurized irrigation fluid source 1105 so as to maintain the desired IOP . During occlusion break, the controller typically directs the pressurized source of irrigation fluid 1105 to deliver a fluid at increased pressure to maintain the IOP. Maintaining pressure during occlusion break is likely to mean that plates 1106 and 1107 exert force on flexible bag 1109 to increase pressure in the irrigation line to provide the fluid flow needed to satisfy the peak fluid demand. . In addition, the controller calculates an estimated value for fluid flow, as modified by the compensation factor, as detailed above. Since the irrigation fluid flow (estimated flow through the system as modified by the offset factor) is related to the IOP, the controller 1230 directs the operation of the pressurized irrigation fluid source 1105 to maintain a flow rate consistent with the desired IOP. The net result is that the compensation factor is used to adjust the fluid pressure for the pressurized irrigation fluid source 1105 to compensate for flow losses (eg, incision leakage).
[071] In another embodiment of the present invention, incision leakage can be determined as the difference between irrigation fluid flow and aspiration fluid flow. Irrigation fluid flow can be measured directly with a flow sensor, it can be calculated using a differential pressure measurement, or it can be calculated based on the plate path. The readings from the 1110 Supply Pressure Sensor and the 1130 Irrigation Pressure Sensor can be used to perform a differential pressure measurement. In this case, the flow impedance between the source pressure sensor 1110 and the irrigation pressure sensor 1130 is known (or can be measured). The difference between the pressure readings measured by the source pressure sensor 1110 and the irrigation pressure sensor 1130 can be calculated and the flow determined. In the case of plate travel, the flow can be estimated from the position and/or movement of plates 1106 and 1107.
[072] Aspiration fluid flow can also be calculated using a differential pressure measure. Flow can be calculated by the difference between the suction pressure measured on the suction pressure sensor 1160, the maximum vacuum that can be created by an 1170 pump, and the pump impedance. The impedance of the 1170 pump is a known parameter and the maximum vacuum that the pump creates can be accurately measured as well as the suction pressure (by suction pressure sensor 1160). In this way, the flow is estimated by the difference of two pressures in the fluid path and the impedance of that path. In this case, the two pressures are the pressure measured by the suction pressure sensor 1160 and the maximum pressure achievable by the pump 1170. The impedance in the present example is the impedance of the pump 1170.
[073] Using the calculated values for irrigation flow and aspiration flow, one can find incision leakage as the difference between irrigation flow and aspiration flow. This incision leakage calculation can then be used to more accurately determine the compensation factor. In one embodiment of the present invention, the compensation factor is dynamically determined based, in part, on the calculated incision leaks.
[074] Finally, it should be noted that the position of plates 1106 and 1107 can be used to indicate the volume of fluid used during the procedure left inside flexible bag 1109. As mentioned above, the relative position of opposing plates 1106 and 1107 indicates the volume of fluid that has exited flex bag 1109. In some cases, a new irrigation fluid bag may need to be installed in pressurized irrigation fluid source 1105, if the existing flex bag 1109 has low fluid. Since the relative position of opposing plates 1106 and 1107 indicates the volume of fluid used, and since the total volume of fluid in flexible bag 1109 is known, these two parameters can be used to provide an indication to the surgeon of the level of fluid in flexible bag 1109 (for example, when displaying the fluid level on the 1220 monitor). If the fluid level is low, a warning can be given to the surgeon so that a new flexible bag 1109 of fluid can be installed in the pressurized irrigation fluid source 1105.
[075] From the foregoing, it can be appreciated that the present invention provides an improved phacoemulsification system. The present invention provides active pressure control in the eye during the surgical procedure. The present invention is illustrated herein by example, and various modifications can be made by a person skilled in the art.
[076] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples are intended to be regarded as exemplary only, with the true scope and spirit of the invention indicated by the following claims.
权利要求:
Claims (19)
[0001]
1. A method for controlling a surgical system having a fluid flow path, comprising: a source of pressurized irrigation fluid (1105); an irrigation line (1140) fluidly coupled to the source of pressurized irrigation fluid; a handpiece (1150) fluidly coupled to the irrigation line, the handpiece including an irrigation glove; an irrigation pressure sensor (1130) located at or along the pressurized irrigation fluid source or irrigation line; and a controller (1230) for controlling the source of pressurized irrigation fluid; characterized in that it further comprises: receiving a pressure reading from an irrigation pressure sensor (1130) located along the fluid flow path; calculate an estimated fluid flow through the surgical system; modify the estimated fluid flow with a compensation factor; and controlling a source of pressurized irrigation fluid (1105) based on the pressure reading and estimated fluid flow, as modified by the offset factor, said offset factor based on irrigation glove compression that restricts the flow of the irrigation fluid.
[0002]
2. Method according to claim 1, characterized in that the compensation factor is still based on incision leakage.
[0003]
3. Method according to claim 1, characterized in that it further comprises: receiving a desired value of intraocular pressure; and controlling the source of pressurized irrigation fluid (1105) so as to maintain the desired intraocular pressure value.
[0004]
4. Method according to claim 1, characterized in that it further comprises: receiving a desired intraocular pressure range; and controlling the source of pressurized irrigation fluid (1105) so as to maintain the desired intraocular pressure range.
[0005]
5. Method according to claim 1, characterized in that it further comprises calculating an intraocular pressure of an eye, based on the reading of the irrigation pressure sensor (1130).
[0006]
6. Method according to claim 1, characterized in that it further comprises calculating an intraocular pressure of an eye, based on the estimated flow value modified by the compensation factor.
[0007]
7. Method according to claim 1, characterized in that the calculation of the estimated flow value further comprises: receiving a reading from an aspiration pressure sensor (1160) located along the fluid path, a vacuum of maximum pump attainable by the suction pump (1170) and a suction pump impedance; and estimate the flow based on a difference between the suction pressure sensor reading and the maximum pump vacuum attainable by the suction pump.
[0008]
8. Method according to claim 1, characterized in that the calculation of the estimated flow value further comprises: receiving a reading from the irrigation pressure sensor (1130), a reading from a source pressure sensor (1110 ) and an impedance of the fluid flow path between the source pressure sensor and the irrigation pressure sensor; and estimate flow based on a difference between the reading of the irrigation pressure sensor and the source pressure sensor.
[0009]
9. Method according to claim 1, characterized in that the compensation factor is based on a needle and a glove selected for a procedure.
[0010]
10. Method according to claim 1, characterized in that it further comprises receiving a compensation factor from a user.
[0011]
11. Method according to claim 1, characterized in that it further comprises: receiving the needle and glove information; and use the needle and glove information to select or calculate the offset factor.
[0012]
12. Method according to claim 11, characterized in that the selection or calculation of the compensation factor is based on fluid flow characteristics of a combination of needle and glove.
[0013]
13. The method of claim 1, further comprising: receiving a pressure reading from an aspiration pressure sensor (1160) located along the fluid path; and using the pressure reading from the aspiration pressure sensor to determine if an occlusion is present or if an occlusion break occurs.
[0014]
14. Method according to claim 13, characterized in that controlling the pressurized irrigation fluid source (1105) further comprises accommodating changes in fluid flow that result from occlusion or occlusion breakage.
[0015]
15. Method according to claim 1, characterized in that it further comprises: receiving a pressure reading from the irrigation pressure sensor (1130); and use the pressure reading from the irrigation pressure sensor to determine if an occlusion is present or if an occlusion break occurs.
[0016]
16. The method of claim 15, characterized in that controlling the pressurized irrigation fluid source (1105) further comprises accommodating changes in fluid flow that result from occlusion or occlusion breakage.
[0017]
17. Method according to claim 2, characterized in that it further comprises the calculation of incision leakage by: calculating the flow of irrigation fluid; calculate aspiration fluid flow; and subtracting the calculated aspiration fluid flow from the calculated irrigation fluid flow; wherein the calculated irrigation fluid flow and the calculated aspiration fluid flow are determined from differential pressure measurements.
[0018]
18. Method according to claim 17, characterized in that the differential pressure measurement for the calculated irrigation fluid flow is based on readings from two pressure sensors located along an irrigation line (1140) and an irrigation line impedance between the two pressure sensors.
[0019]
19. Method according to claim 17, characterized in that the differential pressure measurement for the calculated aspiration fluid flow is based on a reading from an aspiration pressure sensor (1160) located along a line suction (1155), a maximum vacuum level achievable by a suction pump (1170) and a suction pump impedance.
类似技术:
公开号 | 公开日 | 专利标题
BR112015008307B1|2021-06-01|METHOD FOR CONTROLLING A SURGICAL SYSTEM HAVING A FLUID FLOW PATH
BR112015005502B1|2021-05-11|surgical system
US20110313343A1|2011-12-22|Phacoemulsification Fluidics System Having a Single Pump Head
AU2013360295A1|2015-03-05|Phacoemulsification hand piece with integrated aspiration and irrigation pump
WO2018020426A1|2018-02-01|Pressure control in phacoemulsification system
US20180318131A1|2018-11-08|Pressure control in phacoemulsification system
同族专利:
公开号 | 公开日
JP2015532171A|2015-11-09|
CN104640581A|2015-05-20|
US20140114237A1|2014-04-24|
EP2869863B1|2016-09-21|
KR20150080481A|2015-07-09|
MX364039B|2019-04-11|
EP2869863A1|2015-05-13|
CA2881401C|2021-04-13|
CA2881401A1|2014-05-01|
PH12015500336A1|2015-04-20|
US9119699B2|2015-09-01|
WO2014066061A1|2014-05-01|
KR102182495B1|2020-11-25|
JP6352934B2|2018-07-04|
AU2013335088A1|2015-03-05|
BR112015008307A8|2018-03-06|
CN104640581B|2018-02-23|
EP2869863A4|2015-09-09|
ES2606837T3|2017-03-28|
MX2015003205A|2015-07-14|
BR112015008307A2|2017-07-04|
AU2013335088B2|2017-06-22|
RU2015119232A|2016-12-10|
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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2020-03-17| B25A| Requested transfer of rights approved|Owner name: ALCON RESEARCH, LLC (US) |
2020-03-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2021-06-01| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/10/2013, OBSERVADAS AS CONDICOES LEGAIS. |
2021-06-29| B25A| Requested transfer of rights approved|Owner name: ALCON INC. (CH) |
优先权:
申请号 | 申请日 | 专利标题
US13/657,234|US9119699B2|2012-10-22|2012-10-22|Pressure control in phacoemulsification system|
US13/657,234|2012-10-22|
PCT/US2013/064434|WO2014066061A1|2012-10-22|2013-10-11|Pressure control in phacoemulsification system|
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