Ophthalmic surgical system for treating an eye, as well as methods for providing intraocular pressure information and / or patient eye level information using an ophthalmic surgical system

Abstract

The invention relates to an ophthalmic surgical system (1) for treating an eye (2) and a method. The ophthalmic surgical system (1) comprises a pressure sensor (12) that detects pressure information, which describes at least the pressure exerted on the pressure sensor (12) by a treatment fluid and, in the case of a handpiece (9) or infusion element at least partially inserted into the eye (2), the pressure exerted on the pressure sensor (12) by the intraocular pressure of the eye (2). A time course (30) of the pressure information is determined and analyzed to determine whether a pressure information increase (31) is discernible, in which the pressure information increases in steps from a first pressure information (32) to a second pressure information (33), wherein a pressure information difference (34) between the two pressure information (32, 33) is greater than a predetermined minimum value (36).If the pressure information increase (31) is detected, patient eye level information (38) and / or intraocular pressure information (37) is determined and provided by applying an evaluation algorithm (42) to the first pressure information (32) and / or the second pressure information (33).

Description

[0001] The invention relates to an ophthalmic surgical system for treating an eye. Furthermore, the invention relates to a method for providing intraocular pressure information, which describes the intraocular pressure of an eye, and / or patient eye height information, which describes the height of the eye relative to a reference point of an ophthalmic surgical system, by means of such an ophthalmic surgical system.

[0002] An ophthalmic surgical system is suitable for treating an eye, for example, during cataract surgery, in which a patient's eye has a clouding of the lens, known as a cataract. Phacoemulsification is particularly common in this context. In this procedure, a thin hollow needle is inserted into the capsular bag of the eye being treated and vibrated within the bag. This shatters the lens, releasing lens particles into the eye. These particles are then aspirated through an aspiration tube of the ophthalmic surgical system. Simultaneously, a treatment fluid, also called irrigation fluid, is introduced into the eye. Once the lens has been completely removed, a new artificial lens can be inserted into the emptied capsular bag.This means, for example, that the treated patient can achieve improved vision compared to their vision before the operation.

[0003] The ophthalmic surgical system can be trained, either as an alternative or in addition to its primary function, to perform posterior segment surgery on the eye. An example of posterior segment surgery is a vitrectomy, or vitreous aspiration. During a vitrectomy, a suction-cutting instrument of the ophthalmic surgical system is inserted through an opening in the eye to remove a portion of the vitreous humor, which is then filled with treatment fluid or another specialized fluid. After filling, for example, a diseased area of ​​the retina can be treated. Vitrectomy is therefore suitable for removing at least part of the vitreous humor, particularly in cases of diabetic retinopathy, retinal detachment, and / or vitreous hemorrhage.

[0004] The administration of the treatment fluid also serves to maintain a constant intraocular pressure in the patient's eye. If the treatment fluid is not administered, or not administered in sufficient quantities, the intraocular pressure can drop due to suctioning. Fluctuations in intraocular pressure can, however, lead to injuries of the capsular bag or to hyper- or hypotony, which can result in retinal detachment, bleeding in the eye, and / or glaucoma.

[0005] Typically, an intraocular pressure (IOP) value, representing an assumption or estimate of the patient's actual IOP, is assumed by the user of the ophthalmic surgical system and set, for example, using a control element of the system. This assumed IOP depends, for instance, on the patient's actual IOP, which was determined during a pre-operative examination. To ensure the most accurate possible assumption of the patient's IOP, not only is the patient's actual IOP relevant, but also the patient's eye height—that is, the height of the patient's eye relative to a reference point of the ophthalmic surgical system—must be considered, as this can, for example, influence the delivery of the treatment fluid to the eye.If the assumed intraocular pressure is sufficiently accurate and the patient's eye level is known, the ophthalmic surgical system can, for example, specify the flow of the treatment fluid to the eye and the drainage of the aspiration fluid in the aspiration line in such a way that the actual intraocular pressure can be kept constant.

[0006] US patent 2019 / 0099547 A1 discloses a system for measuring actual intraocular pressure during phacoemulsification surgery. The system uses two different sensors to determine pressure values, and the actual intraocular pressure is calculated based on the difference between these two values.

[0007] EP 2 869 801 B1 describes a pressure control system in a phacoemulsification system. It allows the calculation of the actual intraocular pressure of an eye based on readings from an irrigation pressure sensor.

[0008] Furthermore, systems and procedures are known, as shown for example in JP 6997093 B2, in which a pressure sensing system is inserted into the eye of the patient in order to determine the actual intraocular pressure of the eye.

[0009] The object of the invention is to provide a solution by means of which intraocular pressure and / or patient eye level can be determined accurately and quickly.

[0010] The problem is solved by the subject matter of the independent patent claims.

[0011] A first aspect of the invention relates to an ophthalmic surgical system for treating an eye. For example, cataract surgery and / or posterior segment surgery can be performed using this ophthalmic surgical system. Other uses of the ophthalmic surgical system may be possible.

[0012] The ophthalmic surgical system comprises a console. The console includes at least one fluid pump for delivering a treatment fluid. In one example, the console may have a cassette receptacle. In this example, the ophthalmic surgical system may include a cassette that can be inserted into the cassette receptacle of the console. The cassette may include at least one fluid pump for delivering the treatment fluid. The treatment fluid may alternatively be referred to as irrigation fluid. In a preferred example, the treatment fluid is a liquid, in particular an irrigation fluid. A balanced electrolyte solution or balanced salt solution (BSS) suitable as an intraocular irrigation solution for ophthalmic surgical procedures is particularly suitable as a treatment fluid.

[0013] The ophthalmic surgical system comprises an ophthalmic surgical handpiece for treating a patient's eye. The ophthalmic surgical handpiece is at least partially insertable into the eye for treatment. The handpiece is coupled to the console, at least indirectly. It can be coupled directly to the console. Alternatively, the handpiece can be coupled to the cassette, meaning it is connected to the console via the cassette. The handpiece features, for example, a hollow needle that is inserted into the patient's eye by a user, particularly a surgeon, during cataract surgery. The treatment fluid can be introduced into the eye through the handpiece to maintain constant intraocular pressure while simultaneously aspirating the fragmented lens and aspirated fluid via an aspiration line of the ophthalmic surgical system.The ophthalmic surgical system includes typical components of an aspiration line or aspiration port. The handpiece can alternatively or additionally be designed as a cutting instrument, which can be used, for example, to cut open the vitreous humor of the eye during posterior segment surgery.

[0014] The ophthalmic surgical system includes, as an alternative to the ophthalmic surgical handpiece, an infusion element for delivering the treatment fluid into the eye. This infusion element can be at least partially inserted into the eye and is coupled to the console or cassette. Therefore, the treatment fluid can be pumped into the eye via the infusion element without the handpiece.

[0015] The ophthalmic surgical system includes a treatment fluid reservoir located outside the console. The treatment fluid can be supplied from the reservoir to at least one fluid pump. From the pump, it can be pumped to the ophthalmic surgical handpiece or infusion element. Thus, for example, it can be pumped to the ophthalmic surgical handpiece or infusion element by means of the pump. The treatment fluid reservoir is designed, for example, as a bottle or bag. The treatment fluid reservoir can be positioned at a predetermined height relative to a reference point on the console, particularly the cassette, by means of a holding device within the ophthalmic surgical system. The treatment fluid reservoir is detachably held in place by this holding device.The treatment fluid reservoir can, for example, be suspended from the holding device or attached in some other way. The treatment fluid reservoir is connected to the console or directly to the cassette via a supply line, in particular a hose.

[0016] For the sake of simplicity, the following examples assume that the ophthalmic surgical handpiece is available. However, these examples apply analogously to the case where the infusion element is available.

[0017] The ophthalmic surgical system features a pressure sensor designed to detect pressure information. This pressure information describes at least the pressure exerted on the sensor by the treatment fluid. When the handpiece is inserted into the eye, the pressure information also includes the pressure exerted on the sensor by the intraocular pressure. Therefore, the pressure information can be composed of several individual pressures resulting from the treatment fluid and, when the handpiece is inserted, from the eye itself.

[0018] The pressure sensor is located, for example, between the at least one fluid pump and the ophthalmic surgical handpiece. The pressure sensor can be designed as a force sensor. If, for example, the valves of the at least one fluid pump are open, the hydrostatic pressure of the treatment fluid in the treatment fluid reservoir acts on the pressure sensor. In addition, the treatment fluid in tubing, lines, and / or other parts of the ophthalmic surgical system, particularly the console and / or cassette, exerts pressure on the pressure sensor. Furthermore, if the ophthalmic surgical handpiece is inserted into the patient's eye, the intraocular pressure of the eye acts on the pressure sensor, since the eye is connected to the console or cassette via the handpiece. It is therefore possible to obtain information about the patient's eye based on the pressure information from the pressure sensor.

[0019] The ophthalmic surgical system is designed to determine the temporal progression of pressure information acquired by the pressure sensor. Furthermore, the system is designed to analyze whether a pressure increase is detectable, where the pressure rises in steps from an initial pressure reading to a second, higher reading. For this purpose, the determined temporal progression of the pressure information is analyzed, i.e., evaluated. The system is also designed to analyze whether, during the detected step-like pressure increase, the pressure difference between the first and second readings exceeds a predefined minimum value.

[0020] If such an increase in pressure information is detected, that is, if the pressure information difference between the first pressure information and the second pressure information is greater than the specified minimum value and, in addition, the step-like increase in pressure information is observed, patient eye level information and / or intraocular pressure information can be determined and provided by applying an evaluation algorithm to the first pressure information and / or the second pressure information.The ophthalmic surgical system is therefore designed to determine and provide the patient's intraocular pressure information by applying the evaluation algorithm to the first and / or second pressure information if a pressure increase is detected, in which the pressure information rises in steps from an initial pressure reading to a second pressure reading that is higher than the first, and in which the pressure difference between the first and second pressure readings exceeds a predefined minimum value. The predefined minimum value could, for example, be 10 millimeters of mercury (mmHg). Depending on the patient and / or the user's experience, the minimum value could be higher, for example, 20 mmHg or 30 mmHg, or lower.The minimum value can, for example, be greater than 0 mmHg and less than 10 mmHg, particularly at 3 mmHg, 5 mmHg, or 8 mmHg. Minimum values ​​between these examples are possible, and these values ​​can be any real number between the given values.

[0021] The evaluation algorithm comprises at least one rule and / or procedure that, when applied, allows the calculation of intraocular pressure (IOP) information and / or patient eye level information, using at least one of these two pressure values. A single evaluation algorithm may be used to determine both IOP and patient eye level information. Alternatively, two different evaluation algorithms may be used: one for determining IOP and the other for determining patient eye level.

[0022] The first pressure reading describes the pressure on the pressure sensor before the ophthalmic surgical handpiece is inserted into the eye. The second pressure reading describes the pressure on the pressure sensor after the ophthalmic surgical handpiece has been inserted into the eye. The pressure reading increase from the first to the second reading describes the increase in pressure on the pressure sensor during the insertion of the ophthalmic surgical handpiece into the eye. The pressure reading increase is described as stepwise if both the first pressure reading before the increase and the second pressure reading after the increase remain essentially constant for at least a minimum period. "Essentially constant" here refers to fluctuations in the pressure reading of, for example, up to 1 percent, 2 percent, 3 percent, 5 percent, 10 percent, 15 percent, or, in particular, 20 percent.The minimum duration can be, for example, 0.5 seconds, 1 second, 2 seconds, 5 seconds, or, in particular, 10 seconds. Values ​​between the mentioned percentages and / or seconds are possible, and these can be any real number between the examples given.

[0023] Intraocular pressure (IOP) information describes the intraocular pressure of the patient's eye. IOP can also be referred to as intraocular pressure. Patient eye level (PEL) information describes the patient eye level, that is, the height of the eye relative to a reference point within the ophthalmic surgical system. The reference point is, for example, the location of the pressure sensor within the ophthalmic surgical system. The reference point may be the same as, or different from, the reference point for the treatment fluid reservoir. Patient eye level information thus describes the vertical distance between the patient's eye and the pressure sensor of the ophthalmic surgical system. Patient eye level can be abbreviated as PEL.

[0024] The provided intraocular pressure information and / or the provided patient eye level information can be used, for example, in the further use of the ophthalmic surgical system, especially in the context of eye surgery, or at least displayed to the user.

[0025] The ophthalmic surgical system may include a control device that is at least designed to evaluate the temporal course of the pressure information, i.e., to analyze it, and, if necessary, to apply the evaluation algorithm, i.e., to determine and provide the intraocular pressure information and / or the patient's eye level information.

[0026] The ophthalmic surgical system reliably determines both intraocular pressure (IOP) and patient eye level based on the temporal profile of pressure information captured by a single pressure sensor. To determine IOP and / or patient eye level, the system utilizes the fact that a sudden pressure increase occurs during the insertion of the handpiece into the eye, for example, with the needle tip of the handpiece. This sudden pressure increase is detected by the pressure sensor. This sudden pressure increase results from the pressure exerted on the sensor not only by the treatment fluid but also by the eye itself.The pressure sensor of the ophthalmic surgical system detects a significant pressure increase of, for example, several mmHg during the insertion of the handpiece into the eye. This increase occurs within a relatively short timeframe and can be clearly identified. By using the data from the pressure sensor of the ophthalmic surgical system, particularly the pressure difference between the first and second pressure readings during the stepwise pressure increase, the intraocular pressure and / or the patient's eye level can be calculated accurately and quickly. This is also cost-effective, as no additional components are required to determine the intraocular pressure and / or the patient's eye level using the ophthalmic surgical system.

[0027] One embodiment provides that the ophthalmic surgical system is configured to apply the evaluation algorithm to the initial pressure information to determine the patient's eye level, taking into account at least one empirical constant. This at least one empirical constant is, in particular, the density of the treatment fluid and the acceleration due to gravity. This approach is based, at least in part, on the understanding that the patient's eye level can be calculated, at least approximately, by dividing the initial pressure information (divided by the at least one empirical constant, in particular the product of the density of the treatment fluid and the acceleration due to gravity) (divisor). The evaluation algorithm used to determine the patient's eye level can alternatively be referred to as the initial evaluation algorithm or the patient eye level evaluation algorithm.The evaluation algorithm comprises at least one rule and / or procedure which, when applied to the initial pressure information and at least one empirical constant, in particular the density of the treatment fluid and the acceleration due to gravity, allows the calculation of the patient's eye level information. The density of the treatment fluid and the acceleration due to gravity are assumed to be known values. Using the pressure sensor's measurement data, i.e., the initial pressure information, the patient's eye level information can therefore be reliably determined. This demonstrates how the patient's eye level information can be determined and provided accurately and quickly.

[0028] Another embodiment involves the ophthalmic surgical system being designed to apply the evaluation algorithm to the first and second pressure readings to determine the intraocular pressure (IOP). The difference between these two readings represents the IOP. This approach is based on the understanding that the second IOP differs from the first due to the contribution of the IOP. The difference between the first and second IOP readings therefore yields the IOP. Consequently, no further complex calculations or data acquisition are required to calculate the IOP after analyzing the temporal progression of the pressure readings. The IOP can thus be determined quickly and easily.

[0029] The evaluation algorithm used to determine intraocular pressure information can alternatively be referred to as the second evaluation algorithm or the intraocular pressure evaluation algorithm. The evaluation algorithm comprises at least one rule and / or procedure which, when applied to the first and second pressure information, allows the calculation of the intraocular pressure information.

[0030] Another embodiment provides that the ophthalmic surgical system is designed to only consider pressure information acquired within a predefined time window when analyzing the temporal progression of pressure data. This ensures that any pressure increase extending over a period longer than the predefined time window is not used to determine intraocular pressure and / or the patient's eye level, regardless of whether the pressure difference between the first and second pressure readings exceeds the predefined minimum value.For example, if, for a period longer than the specified time window, it is determined that the pressure information recorded by the pressure sensor increases to such an extent that the pressure information difference achieved by this increase is greater than the specified minimum value, it is possible that the required stepwise pressure information increase is still not present because the specified time window was not adhered to. In this example, the intraocular pressure and / or the patient's eye level are not inferred from the observed pressure information increase. Only if a pressure information increase is observed within the specified time window, where the pressure information difference between the first and second pressure information is greater than the specified minimum value, are the intraocular pressure information and / or the patient's eye level determined as described above.

[0031] The specified time window is, for example, between 2 seconds and 5 seconds, and in particular it can be between 3 seconds and 4 seconds.

[0032] In an alternative example, the specified time window can be between greater than 0 seconds and 10 seconds, specifically between 1 second and 8 seconds. Limits of the specified time window between these time values ​​are possible.

[0033] It is therefore possible to analyze the temporal progression of print information increase not continuously, but rather to consider completed segments of the temporal progression individually. These segments each extend over the specified time window. This ensures that a print information increase that, for example, takes significantly longer than the specified time window, is not further considered. Ultimately, the temporal progression of the print information is divided into segments or packages, each lasting the specified time window, which can then be analyzed individually with regard to the print information increase.

[0034] By specifying the time window, it is ensured that only sudden, and therefore stepwise, pressure increases are considered in order to determine the parameters relevant for setting the ophthalmic surgical system, namely the intraocular pressure information and / or the patient's eye level information. This prevents these parameters from being determined in situations where the pressure increase was not caused by the penetration of the ophthalmic surgical handpiece into the eye, but rather by other factors, for example. Therefore, it is not possible to derive the intraocular pressure information and / or the patient's eye level information from the first and / or second pressure readings in such cases. This results in a particularly reliable determination of the intraocular pressure information and / or the patient's eye level information.

[0035] In one example, the specified minimum value for the pressure information difference might be a multiple of the value that describes the specified time window, for example, in seconds. For instance, with a time window of 5 seconds, the specified minimum value could be 10 mmHg, meaning that, regardless of the units, its value could be twice that of the specified time window.

[0036] One embodiment provides that the ophthalmic surgical system is configured to verify whether the pressure information increase is due to a manual increase in the flow rate of the treatment fluid. If this is not the case, and specifically only if this is not the case, the ophthalmic surgical system is configured to determine the intraocular pressure information and / or the patient's eye level. This approach is based, at least, on the understanding that a user-initiated increase in the flow rate of the treatment fluid to the eye, particularly by the treating physician, typically also results in a pressure information increase, which is detected by the pressure sensor. However, this pressure increase is due to the increased flow rate and therefore cannot contain unfiltered information about the intraocular pressure and / or the patient's eye level.Such manual events are therefore explicitly excluded to avoid inaccurate or even incorrect intraocular pressure information and / or patient eye level information.

[0037] Manually increasing the flow rate is typically detectable by the ophthalmic surgical system, for example, if a corresponding control device of the ophthalmic surgical system, such as a foot pedal for controlling the flow rate, has been activated. Once such activation of the control device is detected, in the case of a step-like increase in pressure information that meets the requirements for determining intraocular pressure and / or patient eye level information, the intraocular pressure and / or patient eye level information will not be determined and provided.

[0038] In one example, an unexpected increase in pressure information might occur if the user, particularly the practitioner, touches the patient's eye with a finger. However, this pressure increase is typically not stepwise but rather iterative. Such a pressure increase can therefore be reliably distinguished from the stepwise pressure increase used to determine intraocular pressure and / or patient eye level, and is thus disregarded. The system is therefore protected against incorrect determinations of intraocular pressure and / or patient eye level due to manual operation of the ophthalmic surgical system and / or user actions.

[0039] Another embodiment provides that the ophthalmic surgical system is designed to keep a valve between the at least one fluid pump and the pressure sensor and / or a valve between the at least one fluid pump and the treatment fluid reservoir closed while the pressure information is being determined over time. Closing the valve between the fluid pump and the pressure sensor prevents treatment fluid from being pumped from the treatment fluid reservoir towards the ophthalmic surgical handpiece by the fluid pump. This measure is suitable, for example, for a fluid pump designed as a pneumatically controlled diaphragm pump.However, if, for example, at least one fluid pump is used that remains in a fixed position and is not affected by extrinsic pressure, closing the valve between the fluid pump and the treatment fluid reservoir can prevent treatment fluid from flowing from the reservoir, through the fluid pump, or towards the ophthalmic surgical handpiece. The fluid pump that remains in the fixed position could be, for example, a diaphragm pump with a piston or a peristaltic pump. Alternatively or additionally to closing the valve, the fluid pump can be switched off, assuming that switching off the fluid pump will prevent the flow of treatment fluid towards the ophthalmic surgical handpiece. Thus, the measures described ensure that no treatment fluid can flow towards the eye.

[0040] If several fluid pumps are included by the console and / or the cassette, in the embodiment described above, all valves located between the respective fluid pump and the pressure sensor, and / or all valves located between the respective fluid pump and the treatment fluid reservoir, are closed.

[0041] In this embodiment, intraocular pressure information and / or the patient's eye level information are determined when the treatment fluid is stationary within the console, cassette, and connected tubing and / or lines. This stillness can be understood as the absence of any flow of the treatment fluid; that is, when stationary, there is no flow of the treatment fluid within the ophthalmic surgical system. This has the advantage that dynamic effects, which can be caused, for example, by the volumetric flow rate of the treatment fluid through the ophthalmic surgical system, are not present and therefore do not need to be taken into account.

[0042] An alternative embodiment provides that the ophthalmic surgical system is designed to allow a flow of treatment fluid from the treatment fluid reservoir to the ophthalmic surgical handpiece or infusion element while the pressure information is being determined over time. In this case, for example, the valve described above between the at least one fluid pump and the pressure sensor is open. It can be assumed, for example, that all valves within the cassette and / or the console that could prevent or at least restrict the flow of treatment fluid are open. The flow of treatment fluid results in a volumetric flow of treatment fluid to the eye.

[0043] The ophthalmic surgical system is specifically designed to consider at least the volumetric flow rate of the treatment fluid to the ophthalmic surgical handpiece when applying the evaluation algorithm. Information about the flow of the treatment fluid is thus acquired and taken into account. The ophthalmic surgical system may, for example, include a sensor unit designed to determine the flow rate of the treatment fluid and thus the volumetric flow rate. When determining and / or considering the volumetric flow rate, dimensions of the tubing and / or lines of the ophthalmic surgical system through which the treatment fluid flows may be considered, particularly their lengths and / or diameters. Furthermore, the type of ophthalmic surgical handpiece and / or cassette used may influence the volumetric flow rate.It is assumed that this information regarding the dimensions, the cassette, and / or the ophthalmic surgical handpiece is known and can therefore be taken into account when evaluating the pressure sensor's pressure information. Even with treatment fluid flow, the intraocular pressure and / or the patient's eye level can thus be accurately determined.

[0044] In an additional embodiment, the pressure sensor is arranged in the console and / or in the cassette inserted into the cassette receptacle of the console. Alternatively, the pressure sensor is encompassed by the ophthalmic surgical handpiece. In a preferred example, the pressure sensor is located between the at least one fluid pump and the ophthalmic surgical handpiece and is encompassed by the console and / or cassette. However, it is also possible to use a pressure sensor in the handpiece, for example, if no pressure sensor is present or desired in the console or cassette. The pressure sensor is thus positioned at a suitable location within the ophthalmic surgical system to reliably detect the pressure increase.

[0045] An additional embodiment includes the ophthalmic surgical system being configured to output the provided intraocular pressure information and / or patient eye level information via an output device of the ophthalmic surgical system. The output device is, for example, a display device, in particular a screen. Alternatively or additionally, the ophthalmic surgical system can include a loudspeaker device with at least one loudspeaker that can output the intraocular pressure information and / or patient eye level information audibly. The output allows the user to be informed which intraocular pressure and / or patient eye level was determined by the ophthalmic surgical system.

[0046] The user, particularly the practitioner, can then decide whether or not to consider the provided intraocular pressure (IOP) and / or patient eye level information when using the ophthalmic surgical system. If the user chooses to use this information, they can, for example, specify that the control of the treatment fluid flow to the eye should be based on the provided IOP and / or patient eye level information. This allows the user, especially the practitioner, to decide whether to trust the automatically determined IOP and / or patient eye level information or to proceed without it.This is particularly convenient for the user, as the ophthalmic surgical system assists him in specifying the intraocular pressure and / or the patient's eye level, but it remains clear which values ​​for intraocular pressure and / or the patient's eye level are actually used by the ophthalmic surgical system.

[0047] In an alternative or additional example, the ophthalmic surgical system is designed to automatically control at least one function based on the provided intraocular pressure (IOP) and / or patient eye level information. In one example, this function is the adjustment of the treatment fluid flow rate to the ophthalmic surgical handpiece, i.e., the volumetric flow rate of the treatment fluid. This eliminates the need for manual input of the IOP and / or patient eye level, as these two values ​​are always automatically determined and set by the ophthalmic surgical system. This is particularly convenient for the user of the ophthalmic surgical system.

[0048] The invention relates to an ophthalmic surgical system for treating an eye. The ophthalmic surgical system comprises at least one pressure sensor capable of detecting pressure information, which describes at least the pressure exerted on the pressure sensor by a treatment fluid and, in the case of a handpiece or infusion element at least partially inserted into the eye, the pressure exerted on the pressure sensor by the intraocular pressure of the eye. A temporal profile of the pressure information is determined and analyzed to determine whether a pressure information increase is discernible, whereby the pressure information rises in steps from a first pressure information to a second pressure information, wherein the pressure information difference between the two pressure information is greater than a predetermined minimum value.If the pressure information increase is detected, an intraocular pressure information and / or a patient eye level information is determined and provided by applying an evaluation algorithm to the first pressure information and / or the second pressure information.

[0049] Another aspect of the invention relates to a method for providing intraocular pressure information, describing the intraocular pressure of an eye, and / or patient eye height information, describing the height of the eye relative to a reference point of an ophthalmic surgical system, by means of the ophthalmic surgical system. The ophthalmic surgical system comprises: - a console comprising at least a part of at least one fluid pump for conveying a treatment fluid, wherein it in particular comprises a cassette receiving area for receiving a cassette with at least a part of the at least one fluid pump for conveying the treatment fluid, - an ophthalmic surgical handpiece for treating an eye lens or an infusion element for supplying a treatment fluid into the eye, wherein the ophthalmic surgical handpiece or the infusion element is at least partially insertable into the eye and at least indirectly coupled to the console, - a treatment fluid reservoir located outside the console, from which the treatment fluid can be supplied to at least one fluid pump and pumped from there to the ophthalmic surgical handpiece or the infusion element, and - a pressure sensor designed to detect pressure information that describes at least a pressure exerted on the pressure sensor by the treatment fluid and, in the case of the handpiece or infusion element being at least partially inserted into the eye, a pressure exerted on the pressure sensor by an intraocular pressure of the eye.

[0050] The procedure involves determining and analyzing the temporal progression of pressure information to identify any pressure increase, where the pressure rises in steps from an initial pressure reading to a second, higher reading, provided the pressure difference between the first and second readings exceeds a predefined minimum value. If such a pressure increase is detected, an evaluation algorithm is applied to the initial and / or second pressure readings to determine and provide the patient's eye level and / or intraocular pressure information.

[0051] The embodiments described in connection with the ophthalmic surgical system according to the invention, both individually and in combination with one another, apply accordingly, insofar as applicable, to the method according to the invention. The invention comprises combinations of the described embodiments.

[0052] For the sake of completeness, the following explains how the treatment fluid can be pumped from the treatment fluid reservoir to the handpiece by means of at least one fluid pump: The fluid pump can, for example, have a pump chamber and a drive chamber separated from the pump chamber by a separating element that is at least partially deflectable. Alternatively, the separating element can be described as a diaphragm arranged between the pump chamber and the drive chamber. In a preferred example, the separating element is elastic, meaning that it can change its shape under the influence of a force and return to its original shape when the force is removed, provided that the elastic limit of a material of the separating element is not exceeded when the force is applied. The change in shape under the influence of the force causes the separating element to be deflected in the direction of the pump chamber or in the direction of the drive chamber.The separating element can therefore be understood as a spring element or spring. The separating element has a stress-free resting state or a stress-free basic form, which can be described as the predetermined stress-free equilibrium position of the separating element. From this resting state or basic form, it can be deflected into a deflected state or shape. A spring constant can be specified for the separating element, which describes the ratio of the applied force to the deflection of the separating element. A drive fluid can be supplied to the drive chamber. The drive fluid is, for example, compressed air. The treatment fluid, for example, the BSS fluid, can be supplied to the pump chamber. The cassette can have several fluid pumps.

[0053] The console can, for example, include a drive fluid supply system for feeding the drive fluid into the drive chamber of the fluid pump. This drive fluid supply system can alternatively be referred to as a compressed air supply system. The drive fluid supply system can, for example, include at least one proportional valve by means of which the drive fluid can be admitted into the drive chamber and thus introduced, or discharged from the drive chamber. As an alternative to the proportional valve, the drive fluid supply system can include a differently configured pressure control and / or pressure measuring device.

[0054] Furthermore, the ophthalmic surgical system can include a sensor unit or sensor device for determining the deflection position of the separating element. The sensor unit is, for example, designed as an inductive displacement sensor. This sensor is designed to detect the movement of a metal plate integrated into the separating element. Alternatively or additionally, this sensor unit can be designed as a Hall sensor, in which case the metal plate is made of a magnetic material.

[0055] The treatment fluid can be fed from the treatment fluid reservoir to the pump chamber of at least one fluid pump in the cassette. For this purpose, it can be routed through the supply line. A clamp may be provided to at least temporarily stop or throttle the flow of the treatment fluid to the console or cassette.

[0056] They show: Fig. 1 a schematic representation of an ophthalmic surgical system with a patient to be treated; Fig. 2 a schematic representation of a section of a cassette of an ophthalmic surgical system; Fig. 3. A schematic representation of the temporal progression of print information; and Fig. Figure 4 shows a schematic representation of a signal flow graph of a method for providing intraocular pressure information and / or patient eye level information.

[0057] In the figures, functionally identical elements are provided with the same reference symbols.

[0058] Fig. Figure 1 shows an ophthalmic surgical system 1 for treating the eye 2 of a patient 3. Here, a patient 3 is depicted as an example, lying on an operating table 4 at the beginning of treatment of their eye 2. The ophthalmic surgical system 1 has a console 5, which may include a cassette receiving area 6 for holding a cassette 7. The console and / or the cassette 7 includes at least part of a fluid pump 8 for supplying a treatment fluid. Furthermore, the ophthalmic surgical system 1 has an ophthalmic surgical handpiece 9 for treating the eye 2. The ophthalmic surgical handpiece 9 is coupled to the console 5, at least indirectly. It can be coupled directly to the console 5 or to the cassette 7, in which case it is coupled to the console 5 via the cassette 7. To treat the lens of eye 2, the ophthalmic surgical handpiece 9 can be at least partially inserted into eye 2.The ophthalmic surgical handpiece 9, for example, has a tip 17, which can be designed as a needle tip or a cutting tip. At least the tip 17 can be inserted into the eye 2 of patient 3. Alternatively, instead of the ophthalmic surgical handpiece 9, an infusion element (not shown here) can be provided, which can be at least partially inserted into the eye 2 to deliver the treatment fluid into the eye 2.

[0059] The ophthalmic surgical system 1 can include a treatment fluid reservoir 11 located outside the console 5, from which the treatment fluid can be supplied to at least one fluid pump 8. The treatment fluid can be pumped from the fluid pump 8 to the ophthalmic surgical handpiece 9. For this purpose, it can be pumped through a connection 10 that connects the ophthalmic surgical handpiece 9 to the cassette 7 or the console 5. The treatment fluid can flow towards the eye 2 via the connection 10. Furthermore, aspiration fluid, for example during cataract surgery, can be aspirated from the eye 2 via the connection 10 and directed to an aspiration fluid collection container, which can be coupled to the cassette 7 or the console 5, for example.

[0060] The ophthalmic surgical system 1 has a pressure sensor 12. The pressure sensor 12 is designed to detect pressure information. This pressure information can, for example, describe at least the pressure exerted on the pressure sensor 12 by the treatment fluid, and, in the case of the handpiece 9 being at least partially inserted into the eye 2, the pressure exerted on the pressure sensor 12 by the intraocular pressure of the eye 2. Depending on the setting of the ophthalmic surgical system 1, the pressure sensor 12 can detect at least one other pressure.

[0061] The ophthalmic surgical system 1 can have an output device 13, which is designed here as a screen. Information can be displayed to a user 16, in particular a treating person such as a physician or surgeon, by means of the output device 13. The ophthalmic system 1 can also have a holding device 14, by means of which the treatment fluid reservoir 11 can be held in a predetermined position. A treatment fluid line 15, which is designed, for example, as a tube, can run between the treatment fluid reservoir 11 and the cassette 7 or the console 5, and through which the treatment fluid can be supplied to the cassette 7 or the console 5.

[0062] A height 18 is indicated, which can alternatively be referred to as the patient's eye level. Height 18 is the height at which the patient's eye 2 is positioned relative to a reference point of the ophthalmic system 1. The reference point is, for example, the location of the pressure sensor 12. In the example sketched here, the pressure sensor 12 is located in the cassette 7. In an alternative example, it could be located in the console 5 and / or encompassed by the ophthalmic surgical handpiece 9.

[0063] Fig. Figure 2 shows an irrigation side of the cassette 7, in which the pressure sensor 12 is located. The cassette 7 can, for example, have two fluid pumps 8 on the irrigation side. These can decouple the respective fluid pump 8 via valves 22, 23, 24, 25 towards the treatment fluid reservoir 11 and thus towards the treatment fluid line 15 or towards the pressure sensor 12 and the connection 10 to the ophthalmic surgical handpiece 9. Each fluid pump 8 can, for example, be assigned a displacement sensor 26 to detect a deflection of a diaphragm of the fluid pump 8. Connections 20, 21 are also shown here, via which the treatment fluid line 15 and the connection 10 to the ophthalmic surgical handpiece 9 can be connected, respectively. The cassette 7 can have an aspiration side, which is not shown here. Other configurations of the cassette 7 are possible.

[0064] Fig. Figure 3 illustrates the basic principle underlying the invention, in which a temporal profile 30 of the pressure information is determined and analyzed. The temporal profile 30 is determined, for example, by means of the pressure sensor 12. Here, time t in seconds (s) is plotted on an x-axis and the pressure p, i.e., the pressure information, in millimeters of mercury (mmHg) is plotted on the y-axis.

[0065] The outlined time course 30 shows an increase in pressure information 31, in which the pressure information rises in steps from an initial pressure information 32 to a second pressure information 33 that is higher than the initial pressure information 32. The pressure information difference 34 between the initial pressure information 32 and the second pressure information 33 is relatively large and can, for example, be at least 10 millimeters of mercury (mmHg).

[0066] Fig. Figure 3 also shows an intraocular pressure curve 35, which can be recorded, for example, by means of a sensor that is inserted into and used in the eye 2. Here it becomes clear that in the area of ​​the pressure information increase 31, a spike in the intraocular pressure curve 35 is also observed.

[0067] The pressure information increase 31 occurs at least whenever the ophthalmic surgical handpiece 9, for example with its tip 17, is inserted into the eye 2 of patient 3, so that a pressure increase due to intraocular pressure is observed. This also leads to a time-limited fluctuation in the intraocular pressure profile 35.

[0068] In Fig. Figure 3 shows a time period Δt during which the pressure information increase 31 is observed. This time period is shorter than a predefined time window, which is denoted here as Δt. maxis designated. Alternatively, the duration can correspond to the specified time window.

[0069] Fig. Figure 4 shows the procedural steps of a method for providing intraocular pressure information 37, which describes the intraocular pressure of eye 2, and / or patient eye height information 38, which describes the height 18 of eye 2 relative to the reference location of the ophthalmic surgical system 1, using the ophthalmic surgical system 1. The method can be performed using a control device of the ophthalmic surgical system 1.

[0070] In process step S1, the pressure sensor 12 is used to determine the temporal profile 30 of the pressure information. In process step S2, the temporal profile 30 is analyzed to determine whether the pressure information increase 31 is discernible, in which the pressure information rises in steps from the first pressure information 32 to the second pressure information 33, where the pressure information difference 34 between the two pressure information is greater than a predefined minimum value 36. For this purpose, for example, the difference between the second pressure information 33 and the first pressure information 32 can be calculated and compared with the minimum value 36. The predefined minimum value 36 is, for example, as in Fig. 3 is shown as an example, at 10 mmHg. Larger or smaller minimum values ​​are possible, which can, for example, be between greater than 0 mmHg and less than or equal to 30 mmHg.

[0071] If the pressure information increase 31, as described above, is detected in procedure step S2, an evaluation algorithm 42 is applied to the first pressure information 32 and / or the second pressure information 33 to determine and provide the patient eye level information 38 (procedure step S3) and / or the intraocular pressure information 37 (procedure step S4).

[0072] In detail, for example, in process step S3, the evaluation algorithm 42 can be applied to the first pressure information 32 and at least one empirical constant, in particular a density 39 of the treatment fluid and an acceleration due to gravity 40, to determine the patient's eye level information 38. Alternatively or additionally, in process step S4, the evaluation algorithm 42 can be applied to the first pressure information 32 and the second pressure information 33, whereby the intraocular pressure and thus the intraocular pressure information 37 can be determined from the pressure information difference 34.

[0073] In one example, a first evaluation algorithm 42 can be differentiated in process step S3, and a second evaluation algorithm 42 can be differentiated in process step S4, which differ at least partially from each other. Alternatively, it can be provided that a common evaluation algorithm 42 is used.

[0074] If, in process step S2, it is determined that the pressure information difference 34 is less than or equal to the specified minimum value 36, process step S1 can be repeated, i.e., the temporal progression 30 can be further determined and analyzed.

[0075] In one example, the ophthalmic surgical system 1 may be configured to analyze the temporal progression 30 only considering or taking into account pressure information acquired within the specified time window. A pressure information increase 31 that extends over a period longer than the specified time window, i.e., for example, longer than Δt, is not considered. maxThis value is not used when determining the intraocular pressure information 37 and / or the patient's eye level information 38, regardless of whether the pressure information difference 34, considered in itself, is greater than the specified minimum value 36. For this purpose, for example, a corresponding check of the time duration can be carried out as part of procedure step S2. The specified time window is, for example, between 2 seconds and 5 seconds.

[0076] It may also be provided that it is checked whether the pressure information increase 31 is due to a manual increase in the volume flow of the treatment fluid, which can be triggered, for example, by pressing a foot pedal of the ophthalmic surgical system 1. Only if this is not the case are the intraocular pressure information 37 and / or the patient's eye level information 38 determined. This check can also be carried out, for example, in procedure step S2.

[0077] In a process step S5, it may be provided that the provided intraocular pressure information 37 and / or patient eye level information 38 is output via the output device 13, i.e., displayed on the screen. Alternatively or additionally, a function 41 of the ophthalmic surgical system 1, such as controlling the treatment fluid flow to the ophthalmic surgical handpiece 9, can be automatically activated depending on the determined intraocular pressure information 37 and / or the patient eye level information 38.

[0078] The procedure described above can only be carried out, for example, if the valve 23, 25 between the respective fluid pump 8 and the pressure sensor 12 and / or the valve 22, 24 between the respective fluid pump 8 and the treatment fluid reservoir 11 is kept closed, thus preventing any treatment fluid from being pumped or flowing towards the ophthalmic handpiece 9. Alternatively, the procedure described above can be performed while the treatment fluid is flowing from the treatment fluid reservoir 11 to the ophthalmic surgical handpiece 9. When applying the evaluation algorithm 42, the volumetric flow rate of the treatment fluid to the ophthalmic surgical handpiece 9 is taken into account. This is detected and / or determined by means of a corresponding sensor device of the ophthalmic surgical system 1. Alternatively, the volumetric flow rate can be estimated.

[0079] Overall, the examples demonstrate automated intraocular pressure detection and / or patient height detection. The fluidic interface of the ophthalmic surgical system 1 includes a force sensor (pressure sensor 12). The pressure sensor 12 is directly connected to the infusion / irrigation line that is inserted into the eye 2 of the patient 3 (either directly via the infusion element or with the handpiece 9 in between).

[0080] An algorithm is required to detect the event of insertion into eye 2, and the pressure immediately before and after is analyzed (the pressure is derived from the force value). The static pressure excess is detected by pressure sensor 12 and represents the intraocular pressure.

[0081] To detect the event of inserting the handpiece 9 or the infusion element, the derived or measured temporal pressure signal p(t) is required. The analysis is performed retrospectively. Therefore, a jump (pressure information increase 31) in the signal (time profile 30) is detected by identifying a large jump in p(t). One possible method is to compare the variation of the signal within the time window and use a multiple of this as a threshold value (minimum value 36). At this step, the variation is much larger than the threshold value, and thus the insertion into the eye 2 is detected. After detection, the intraocular pressure information 37 is determined as the difference between shortly after (second pressure information 33) and shortly before (first pressure information 32) the step. The value measured by the force sensor (pressure sensor 12) shows a small deviation but is sufficient to detect significant changes.

[0082] After the detection of the pressure information increase 31, the PEL value (patient eye level information 38) can be derived from the pressure value shortly before the step (first pressure information 32).

[0083] Pressure sensor 12 is required. Furthermore, calibration of pressure sensor 12 may be crucial to derive the pressure from the force (the p(t) is required). A direct fluidic connection between pressure sensor 12 and eye 2 is necessary, as well as time-based recording of the insertion process. It is irrelevant whether a force sensor or pressure sensor 12 integrated into cassette 7 or a pressure sensor 12 integrated into handpiece 9 is used.

[0084] After determining, for example, the patient eye height information 38, either an automatic adjustment of the patient eye height information 38 can take place in the ophthalmic surgical system 1, or a message is displayed on a graphical user interface (GUI) via the output device 13, for example by indicating that a deviation has been detected. In the latter case, the user 16 can either ignore the message or click a button that takes them directly to the corresponding menu to adjust the patient eye height to the patient eye height information 38. Reference symbol list 1 ophthalmic surgical system 2nd eye 3 patients 4 Operating table 5 console 6 cassette recording area 7 cassette 8 Fluid pump 9 ophthalmic surgical handpiece 10 connection 11 treatment fluid storage vessel 12 Pressure sensor 13 Output device 14 Holding device 15 Treatment fluid line 16 users 17 top 18 Height 20 connection 21 connection 22 valves 23 Valve 24 valve 25 valve 26 Position sensor 30 time course 31 Increase in print information 32 First printing information 33 second print information 34 Print information difference 35 Intraocular pressure trend 36 minimum value 37 Intraocular Pressure Information 38 Patient eye level information 39 Density 40 Earth's gravity 41 Function 42 Evaluation algorithm QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 2019 / 0099547 A1

[0006] EP 2 869 801 B1

[0007] JP 6997093 B2

[0008]

Claims

[1] Ophthalmic surgical system (1) for the treatment of an eye (2), comprising at least: - a console (5) comprising at least a part of at least one fluid pump (8) for pumping a treatment fluid, - an ophthalmic surgical handpiece (9) for treating the eye (2) or an infusion element for supplying the treatment fluid into the eye (2), wherein the ophthalmic surgical handpiece (9) or the infusion element is at least partially insertable into the eye (2) and is at least indirectly coupled to the console (5), - a treatment fluid reservoir (11) arranged outside the console (5), from which the treatment fluid can be supplied to the at least one fluid pump (8) and pumped from there to the ophthalmic surgical handpiece (9) or the infusion element, and - a pressure sensor (12) designed to determine pressure information that describes at least a pressure exerted on the pressure sensor (12) by the treatment fluid and, in the case of the handpiece (9) or infusion element at least partially inserted into the eye (2), a pressure exerted on the pressure sensor (12) by an intraocular pressure of the eye (2), characterized by, that the ophthalmic surgical system (1) is designed to determine a temporal progression (30) of the pressure information and to analyze whether a pressure information increase (31) is detectable, in which the pressure information increases stepwise from a first pressure information (32) to a second pressure information (33) that is higher compared to the first pressure information (32), wherein a pressure information difference (34) between the first pressure information (32) and the second pressure information (33) is greater than a predetermined minimum value (36), and if the pressure information increase (31) has been detected, by applying an evaluation algorithm (42) to the first pressure information (32) and / or the second pressure information (33) a patient eye level information (38) that describes a height (18) of the eye (2) relative to a reference location of the ophthalmic surgical system (1), and / or an intraocular pressure information (37) that describes the intraocular pressure of the eye (2),to determine and provide. [2] Ophthalmic surgical system (1) according to claim 1, characterized by , that the ophthalmic surgical system (1) is designed to apply the evaluation algorithm (42) to the first pressure information (32) to determine the patient's eye level information (38), taking into account at least one empirical constant, in particular a density (39) of the treatment fluid and the acceleration due to gravity (40). [3] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by , that the ophthalmic surgical system (1) is designed to apply the evaluation algorithm (42) to the first pressure information (32) and the second pressure information (33) to determine the intraocular pressure information (37), wherein the pressure information difference (34) between the first pressure information (32) and the second pressure information (33) describes the intraocular pressure. [4] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by , that the ophthalmic surgical system (1) is designed to only consider pressure information obtained within a specified time window when analyzing the temporal course (30) of the pressure information, so that a pressure information increase (31) extending over a period of time greater than the specified time window is not usable for determining the intraocular pressure information (37) and / or the patient's eye level information (38), regardless of whether the pressure information difference (34) between the first pressure information (32) and the second pressure information (33) is greater than the specified minimum value (36). [5] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by, that the ophthalmic surgical system (1) is designed to verify whether the pressure information increase (31) is due to a manual increase in a volume flow of the treatment fluid, and if this is not the case, to determine the intraocular pressure information (37) and / or the patient's ocular height information (38). [6] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by , that the ophthalmic surgical system (1) is designed to keep a valve (23, 25) between the at least one fluid pump (8) and the pressure sensor (12) and / or a valve (22, 24) between the at least one fluid pump (8) and the treatment fluid reservoir vessel (11) closed during the determination of the temporal course (30) of the pressure information. [7] Ophthalmic surgical system (1) according to any one of claims 1 to 5, characterized by, that the ophthalmic surgical system (1) is designed to allow a flow of the treatment fluid from the treatment fluid reservoir vessel (11) to the ophthalmic surgical handpiece (9) or to the infusion element during the determination of the temporal course (30) of the pressure information and, in particular, to take into account at least a volume flow of the treatment fluid in the ophthalmic surgical system (1) when applying the evaluation algorithm (42). [8] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by , that the pressure sensor (12) is arranged in the console (5) and / or in a cassette (7) inserted into a cassette receiving area (6) of the console (5) or is encompassed by the ophthalmic surgical handpiece (9). [9] Ophthalmic surgical system (1) according to any one of the preceding claims, characterized by, that the ophthalmic surgical system (1) is designed to output the provided intraocular pressure information (37) and / or patient eye level information (38) by means of an output device (13) of the ophthalmic surgical system (1) and / or to automatically control at least one function (41) of the ophthalmic surgical system (1) depending on the provided intraocular pressure information (37) and / or patient eye level information (38). [10] Method for providing intraocular pressure information (37) describing an intraocular pressure of an eye (2) and / or patient eye height information (38) describing a height (18) of the eye (2) relative to a reference location of an ophthalmic surgical system (1), using the ophthalmic surgical system (1), wherein the ophthalmic surgical system (1) comprises: - a console (5) comprising at least part of a fluid pump (8) for pumping a treatment fluid, - an ophthalmic surgical handpiece (9) for treating an eye lens of the eye (2) or an infusion element for supplying the treatment fluid into the eye (2), wherein the ophthalmic surgical handpiece (9) or the infusion element is at least partially insertable into the eye (2) and is at least indirectly coupled to the console (5), - a treatment fluid reservoir (11) arranged outside the console (5), from which the treatment fluid can be supplied to the at least one fluid pump (8) and pumped from there to the ophthalmic surgical handpiece (9) or the infusion element, and - a pressure sensor (12) designed to determine pressure information that describes at least a pressure exerted on the pressure sensor (12) by the treatment fluid and, in the case of the handpiece (9) or infusion element at least partially inserted into the eye (2), a pressure exerted on the pressure sensor (12) by an intraocular pressure of the eye (2); characterized by, that a temporal progression (30) of the pressure information is determined and analyzed to determine whether a pressure information increase (31) is detectable, in which the pressure information increases in steps from a first pressure information (32) to a second pressure information (33) that is higher compared to the first pressure information (32), wherein a pressure information difference (34) between the first pressure information (32) and the second pressure information (33) is greater than a specified minimum value (36), and if the pressure information increase (31) has been detected, the patient's eye level information (38) and / or the intraocular pressure information (37) is determined and provided by applying an evaluation algorithm (42) to the first pressure information (32) and / or the second pressure information (33).

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