Docking station for a handheld biometer

Abstract

The invention relates to a docking station for a handheld biometer which can be designed in particular such that a patient can take measurements themselves and document same at home using the biometer. The proposed docking station for a handheld biometer consists of a housing with a device for receiving at least one part of the biometer. According to the invention, the device for receiving a part of the biometer is designed to receive the measuring head of the biometer, wherein a test object for regularly carrying out functional tests and / or calibrations is additionally provided in the housing. The proposed docking station is not just provided for handheld tonometers but can also be used, with a corresponding adaptation of the test objects, for other ophthalmological biometers, which are designed as handheld devices, require a docking station, and are necessary for regular functional tests and / or calibrations.

Description

[0001] Docking station for a handheld biometer

[0002] The present invention relates to a docking station for a handheld biometer, which can in particular also be designed in such a way that a patient can carry out and document the measurements themselves at home.

[0003] Biometers are ophthalmic devices that can be used to perform measurements on the eye. These include, for example, tonometers, axial length measuring devices, keratometers, fundus cameras, and OCT-based measurement systems.

[0004] Handheld solutions for tonometers are already known from the state of the art, which are designed in such a way that even a patient can carry out and document the measurements themselves.

[0005] However, the general trend for other biometric measuring devices, such as axial length measuring devices, keratometers, fundus cameras or OCT-based measuring systems, is also towards miniaturization and, particularly for the management of chronic diseases such as AMD or glaucoma, towards self-measurement by the patient.

[0006] Regardless of the application of miniaturized handheld measuring devices, these measuring systems must be subjected to regular functional tests and / or calibrations. For fundus systems, for example, it is necessary to check that lateral distance measurements still deliver results within specified tolerances, and that axial distance measurements and scattered signal strengths for OCT systems, and the curvature radius determination for keratometers, are performed within the specified tolerances. Long-term stable test objects are particularly suitable for such tests, for example, glass objects with defined lengths, attenuators, defined surface curvatures, and, for example, metallized or laser-inscribed measuring grids.

[0007] The functional test is even more complex for tonometers, since measurements of the intraocular pressure must be ensured over a measuring range, for example from 5 mmHg to 50 mmHg.

[0008] Using a handheld tonometer as an example, the state of the art and the problems associated with miniaturization are explained.

[0009] A tonometer is used to measure intraocular pressure (IOP). An increase above the normal value of this pressure is usually one of the most important, but not the only, risk factor for glaucoma. Lowering the IOP, for example through medication (eye drops or drug-depot implants) or surgical intervention, is the most important therapeutic measure in glaucoma treatment, which is why tonometric monitoring of the IOP is an important tool in guiding therapy. However, glaucoma can also be present when the intraocular pressure is within the above-mentioned normal range (normal-tension glaucoma), and increased intraocular pressure outside the normal range (hypertension) merely justifies suspicion of a disease. There is now also evidence that even strong fluctuations in intraocular pressure are a risk factor for glaucoma.

[0010] Tonometers for measuring intraocular pressure are important diagnostic devices in ophthalmology, particularly for the detection of ocular hypertension, a major risk factor for glaucoma, and for treatment monitoring. They are also used in emergency medicine to detect high intracranial pressures that are transmitted to the eye. State-of-the-art tonometers are handheld devices that can be used by patients themselves to perform and document the measurements.

[0011] For example, DE 102 97 414 T5 describes a handheld non-contact ocular pressure monitor. The objective of this application is a small, lightweight handheld tonometer that measures intraocular pressure, preferably without contact. The described handheld, non-contact tonometer is lightweight, compact, and battery-operated to eliminate the need for power cables. The tonometer also features a fast position detection system and wireless data communication for transmitting measurement data to a remote computer.

[0012] Another mobile tonometer for performing non-contact self-tonometry is described in DE 10 2004 062 337 A1. This tonometer also features an integrated measuring and positioning system. To position the measuring system relative to the subject's eye to be examined, the tonometer includes at least two shaped contact areas for subsequently detecting the position of the eye's cornea and aligning the measuring system.

[0013] WO 2020 / 251691 A1 describes a docking station for a handheld rebound tonometer, which also features a container for disposable probes. With a rebound tonometer, the probe touches the cornea during an intraocular pressure measurement. The intraocular pressure is determined from the deformation upon impact or the speed of the probe's rebound. For hygiene reasons, the part of the measuring probe that comes into contact with the cornea is designed as a disposable part.

[0014] Other handheld applanation tonometers are described, for example, in the following publications: EP 1 121 895 B1, EP 2 856 932 B1, US 2002 / 0173712 A1, WO 2003 / 015624 A1, and WO 2023 / 028373 A1. However, the tonometers described here are not suitable for use by a patient for self-tonometry.

[0015] Tonometers, as medical devices, should be regularly checked for proper function and / or calibrated. This is especially true for tonometers used by patients themselves for regular intraocular pressure measurements.

[0016] Unfortunately, this is a difficult task, as the pressure-dependent interaction of an eye with the respective tonometer is complex, and different pressure levels must be tested. This remains a largely unsolved problem, particularly for dynamic, non-contact tonometers such as airpuff or shockwave tonometers.

[0017] In the state of the art, solutions are known in which substitutes are used that, for example, more or less exactly simulate the reaction of an eye to be measured without contact tonometrically.

[0018] US 2014 / 0323843 A1 describes a tool for calibrating a non-contact tonometer (NCT). The tonometer calibration tool consists of an "electronic eye" that can be positioned in front of an air outlet channel of a non-contact tonometer. It includes a pressure sensor for receiving the air pulse and a transmitter for providing a pseudo-applanation event.

[0019] In particular, the electronic eye simulates the reaction of an eye being measured non-contact by mimicking a pressure-dependent deflection of a light reflex on a "cornea" dynamically deformed by an air puff. However, the light beam is not actually deflected; instead, a similar light signal is generated, dependent on the air puff, which is detected by the air-puff tonometer instead of the deflected light beam.

[0020] It is obvious that the full function of the tonometer cannot be tested with this tool, since the measuring beam of the tonometer is not actually deflected and therefore remains untested.

[0021] State-of-the-art solutions for “test eyes” for non-tonometric applications are also known, for example artificial eyes for handling corneal transplants or for training surgical procedures.

[0022] Furthermore, test objects for diagnostic tabletop devices are known in the prior art, for example, test spheres for keratometers, which must be manually placed on a headrest or a measuring head by the operator before testing the device, or which are part of the measuring device (US 8967808 B2). If test objects are to be placed on the head by the operator, this is cumbersome and requires safe storage to prevent loss, contamination, or damage. If they are part of the measuring device, the problem arises that they either require installation space in the measuring device housing or must sometimes be positioned in front of the measuring head, which is very complex, making the measuring devices larger, heavier, and more complex.

[0023] This approach is therefore completely unsuitable for compact, lightweight, handheld biometers.

[0024] The present invention is therefore based on the task of developing a solution for a handheld biometer that eliminates the disadvantages of the prior art solutions. In particular, the biometer should also be designed so that the patient can perform and document the measurements themselves at home. To this end, the solution should allow regular functional tests and / or calibrations of the biometer to be carried out at home and in the absence of technical personnel.

[0025] This object is achieved by means of a docking station for the handheld biometer, consisting of a housing with a device for receiving at least a part of the biometer, in that the device for receiving a part of the biometer is designed to receive the measuring head of the biometer and that a test object for regularly carrying out functional tests and / or calibrations is additionally present in the housing.

[0026] While the problem is solved by the features of the independent claims, preferred developments and embodiments are the subject of the dependent claims.

[0027] A first advantageous embodiment relates to the test object, which is designed such that it is located directly in front of the measuring head of the biometer accommodated in the device of the housing or can be brought into this position. Particularly preferably, the test object is designed to be configurable and / or positionable.

[0028] “Immediately in front of the measuring head” means that the biometer can immediately perform a measuring function on the test object or can automatically align itself to the test object or the test object can be aligned to the biometer in the docking station without the test object having to be manually inserted or reconnected by an operator to perform functional tests and / or calibrations.

[0029] Typical distances between test objects and biometer measuring heads are often the same as a patient's eye would be in front of the measuring head, for example, 5 to 40 mm. A second group of advantageous designs concerns the connection between the biometer and the docking station housing. One design provides for a contact sensor on the biometer and / or the docking station to signal the insertion of the biometer into the docking station.

[0030] Depending on the test object to be used, both the biometer and the housing can have devices which are designed to establish connections between the biometer and a control unit located in the docking station when the biometer is accommodated in the housing.

[0031] It is advantageous for the docking station to have a trigger that manually or automatically activates a measurement function of the biometer when the biometer is housed in the housing, in order to perform regular functional tests and / or calibrations of the biometer. This trigger can, for example, be a manually operated switch on the housing of the docking station or an automatically acting trigger based on contact or proximity sensors, for example, which regularly initiates a functional test after the biometer has been inserted into the device for accommodating at least part of the biometer or has been there for a certain period of time.

[0032] Particularly preferably, the housing contains a charging station for charging a battery present in the biometer.

[0033] A third group of advantageous embodiments concerns the interaction between the biometer and the control unit. Here, the control unit and / or the biometer itself are configured to activate the biometer's measurement function and to perform regular functional tests and / or calibrations of the biometer.

[0034] Preferably, a schedule is stored in the control unit and / or the biometer to trigger the functional tests and / or calibrations of the biometer regularly or as needed. In particular, the schedule is based on specified intervals or performed activities.

[0035] Particularly preferably, the control unit has an interface for transmitting data to an external device.

[0036] According to a fourth advantageous embodiment, the housing is designed such that it has a device for receiving a binocular biometer, wherein two test objects are present in the housing, which are located directly in front of the two measuring heads of the biometer or can be brought into this position. Although not preferred, it would also be possible to design the docking station for a binocular biometer with only one test object, in that the biometer can be inserted into the device for receiving at least part of the biometer measuring head in the docking station in two orientations, so that each of the two measuring heads can be located in front of the test object. Alternatively, one test object could also be positioned in front of each of the two measuring heads.

[0037] A fifth particularly advantageous embodiment relates to a solution in which the biometer is a tonometer and the test object is a test eye simulating the cornea of ​​the eye.

[0038] The test eye used here, which may have a pressure sensor, is preferably designed to be pressure-adjustable and is connected to a pressure source that has a connection to the control unit.

[0039] According to a further advantageous embodiment, the housing has a dust protection device to protect the test object when the biometer is not in the docking station.

[0040] According to a final advantageous embodiment, the device for receiving at least a part of the biometer has devices which, after insertion, enable a defined position of the measuring head of the biometer relative to the test object within predetermined tolerances.

[0041] The proposed docking station is designed for a handheld biometer, allowing patients to perform and document measurements themselves. The docking station is designed to perform regular functional checks and / or calibrations of the tonometer, even at home and in the absence of technical staff.

[0042] The proposed docking station is not only intended for handheld tonometers, but can also be used, with appropriate adaptation of the test objects, for other ophthalmic biometers that are designed as handheld devices, require a docking station, and require regular functional tests and / or calibrations.

[0043] The invention is described in more detail below using exemplary embodiments.

[0044] Figure 1 : the principle diagram of a docking station for a handheld biometer with a passive test object,

[0045] Figure 2: the principle diagram of a docking station for a handheld tonometer with a pressure-adjustable test object and

[0046] Figure 3: The schematic diagram of a docking station for a binocular, handheld tonometer.

[0047] The proposed docking station for a handheld biometer consists of a housing with a device for receiving at least a part of the biometer. According to the invention, the device for receiving a part of the biometer is designed to accommodate the measuring head of the biometer. Additionally, a test object for regularly performing functional tests and / or calibrations is provided in the housing of the docking station. The test object is preferably designed to be configurable and / or positionable.

[0048] According to the invention, a contact sensor is further provided on the biometer and / or on the docking station, which signals the insertion of the biometer into the docking station.

[0049] The contact sensor can, for example, be a spring-loaded switch activated by the weight of the biometer, an electrical bridge (a spring-loaded metal plate) that closes an electrical circuit upon contact, a magnetic switch triggered by a magnet upon approach, or a light barrier that is interrupted upon contact between the biometer and the docking station or activated by a reflective surface. The contact sensor can be attached to the biometer and / or the docking station. In the latter case, signal connections are required from the contact sensor to the biometer or to a control unit located in the docking station.

[0050] In particular, the test object is designed in such a way that it is located directly in front of the measuring head of the biometer accommodated in the device of the housing or can be brought into this position.

[0051] In principle, test objects that have a structure that differs from the natural anatomy of the eye can be used for testing or calibration.

[0052] Preferably, however, the test object contains at least one structure representing an eye structure, such as a corneal surface, a crystalline lens, or a retina, or combinations thereof. According to a first advantageous embodiment, the test object is designed such that it is located directly in front of the measuring head of the biometer accommodated in the device of the housing or can be brought into this position. Particularly preferably, the test object is designed to be configurable and / or positionable.

[0053] For example, the test object does not have to be positioned directly in front of the measuring head of the biometer incorporated into the housing. Rather, it is also possible to place the test object at a different position within the housing and move it in front of the measuring head only for the measurements, which can be done using a motor, pneumatic, or electromagnetic mechanism.

[0054] A simple, passive test object is one that only specifies length, distance or curvature measurements and generally does not require a control device in the docking station.

[0055] When using a passive test object, a control unit is not required if the functional tests are triggered by the biometer itself. These can be triggered, for example, when the biometer is inserted into the docking station.

[0056] According to a second advantageous embodiment, a contact sensor is provided on the biometer and / or on the docking station, which signals the insertion of the biometer into the docking station.

[0057] Figure 1 shows the schematic diagram of a docking station for a handheld biometer. The docking station 1 shown consists of a housing 2 with a device 3 for receiving a part of the biometer 4, a contact sensor 5 arranged on the housing 2, and a (passive) test object 6.

[0058] The figure also shows a biometer 4 accommodated in the device 3 of the docking station 1. In particular, the device 3 for accommodating the biometer 4 is designed to accommodate the measuring head 4.1 of the biometer 4.

[0059] Depending on the test object to be used, both the biometer and the housing can have devices which are designed to establish connections between the biometer and a control unit located in the docking station when the biometer is accommodated in the housing.

[0060] In addition to contacts, inductive or optical coupling as well as radio connections are also possible as devices for establishing connections between the biometer and the control unit.

[0061] It is advantageous that the docking station has a trigger that manually or automatically activates a measuring function of the biometer when the biometer is in the housing in order to carry out regular functional tests and / or calibrations of the biometer.

[0062] According to a particularly advantageous embodiment, the housing contains a charging station for charging the biometer's battery. This charging can be done via electrical contacts or inductively.

[0063] Further advantageous embodiments relate to the interaction between the biometer and the control unit. The control unit and / or the biometer itself are configured to activate the biometer's measurement function and to perform regular functional tests and / or calibrations of the biometer. A schedule is preferably stored in the control unit and / or the biometer to trigger the functional tests and / or calibrations of the biometer regularly or as needed. In particular, the schedule is based on specified intervals or performed activities.

[0064] Predefined calibration intervals include daily, weekly, monthly, quarterly, half-yearly, annual, or similar. Regular functional tests and / or calibrations can be based on the elapse of a defined time interval or on the number of times the tonometer is used. This is particularly advantageous if measurement-relevant components of the biometer, such as light sources, change due to use or aging. In addition to regular functional tests and / or calibrations, these can also be initiated as needed, for example, if the device needs to be checked by service personnel.

[0065] Activities performed may include, for example, switching on the tonometer, inserting the tonometer into the receiving device, the approach of the operator, or similar activities.

[0066] Regular functional tests and / or calibrations can also be triggered by initiating a measurement from the biometer. Initialization occurs, for example, via a patient schedule from a corresponding Electronic Health Record (EHR) system.

[0067] It is also advantageous if the control unit has an interface for transmitting data to an external device.

[0068] To increase safety and / or accuracy, it is possible for measured values ​​obtained from the patient to be evaluated as valid and / or optimized by recalibration before storage and / or transmission for further use. This is done by conducting a successful test on the test object and / or a calibration measurement immediately before or after the measurement, the results of which are then used for data evaluation and / or optimization.

[0069] According to a further advantageous embodiment, the housing is designed to have a device for accommodating a binocular biometer, wherein two test objects are present in the housing, which are located directly in front of the two measuring heads of the biometer or can be brought into this position. Although not preferred, it would also be possible to design the docking station for a binocular biometer with only one test object, for example, by inserting the biometer into the docking station in two orientations into the device for accommodating at least part of the biometer measuring head. Alternatively, the one test object could also be positioned in front of each of the two measuring heads.

[0070] According to a particularly advantageous embodiment, the biometer is a tonometer and the test object is a test eye simulating the cornea of ​​the eye.

[0071] Preferably, the test eye, which simulates the cornea of ​​the eye, is pressure-adjustable and connected to a pressure source that has a connection to the control unit. Particularly preferably, the test eye also has a pressure sensor that is also connected to the control unit. The adjustable pressure can be used to change, for example, the length and / or curvature of the test eye or its dynamic behavior upon mechanical stimulation (e.g., by means of an air blast, sound pulse, or rebound probe).

[0072] Figure 2 shows the schematic diagram of a docking station for a handheld tonometer. The docking station 1 shown in the left figure consists of a housing 2 with a device 3 for receiving part of the tonometer 7, a contact sensor 5 connected to a control unit 8, and a test eye 9 simulating the cornea. The test eye 9 is connected to a pressure source 10 and has a pressure sensor (not shown), both of which have connections to the control unit 8.

[0073] In contrast, the right-hand figure shows a docking station 1 with a tonometer 7 accommodated therein. In particular, the device 3 for accommodating the tonometer 7 is designed to accommodate the measuring head 7.1 of the tonometer 7, which consists of an excitation unit and a detection unit.

[0074] The docking station for a handheld tonometer can also be designed, as described above, in a particularly advantageous embodiment, such that the housing has a device for accommodating a binocular tonometer. In order to be able to perform regular functional tests and / or calibrations of the tonometer, the invention provides for two test eyes simulating the cornea to be placed in the housing directly in front of the two measuring heads of the tonometer.

[0075] Figure 3 shows the principle diagram of a docking station for a binocular handheld tonometer.

[0076] The docking station 1 shown in the figure consists of a housing 2 with a device 3 for accommodating the binocular tonometer 7, a contact sensor 5 connected to a control unit 8, and two corneal test eyes 9.1 and 9.2, which are connected to a pressure source 10. The binocular tonometer 7 has measuring heads 7.1 and 7.2, in front of which the two corneal test eyes 9.1 and 9.2 are arranged. Pressure-adjustable test eyes for tonometers, as described in the as yet unpublished patent application DE 10 2023 207 473.7, would be preferred.

[0077] The pressure-adjustable test eye described therein is intended for tonometers, especially for non-contact tonometers. Furthermore, the test eye described closely resembles the behavior of the human eye, particularly in the anterior chamber (cornea, iris, and limbus), in terms of mechanical excitation and vibration behavior. The interaction of the foil and damping element allows the minimal reflection of surface waves at the edge of the cornea of ​​the real eye to be simulated.

[0078] When using such a test eye, it is preferably aligned in such a way that the deformation of the corneal replica otherwise caused by gravity is largely avoided. This can be achieved by placing the biometer's measurement axis perpendicularly through the apex of the test eye's corneal replica.

[0079] As an alternative to pressure-adjustable test eyes, substitutes known from the state of the art could also be used, which, for example, more or less accurately simulate the reaction of an eye to be measured without contact tonometric testing.

[0080] According to a further advantageous embodiment, the housing has a dust protection device to protect the test object when the biometer is not in the docking station.

[0081] This particularly applies to the variant in which the test object is positioned directly in front of the measuring head of the biometer housed in the housing, for example, with a cornea-like surface on which dust would accumulate if no dust-protective countermeasures were taken. In the simplest case, a dust protection device could be, for example, a spring-loaded cover flap that seals the housing dust-tight and is pushed aside when the biometer is inserted into the housing. Other dust protection options include brushes that clean the test object or air streams that are briefly activated when the biometer is inserted.

[0082] According to a final advantageous embodiment, the housing has devices that enable repeatably precise positioning of the biometer's measuring head relative to the test object in the docking station after insertion, for example, with tolerances of less than + / - 1 mm, less than + / - 0.25 mm, or even less than + / - 0.1 mm. Such devices can, for example, be interlocking guide rails with defined end stops on the device for receiving at least part of the biometer measuring head of the docking station and on the biometer. Alternatively, spring-loaded guide rollers can be used, which press the biometer into the desired position relative to the test object upon insertion.Another possibility is to realize defined contact surfaces on the biometer housing, for example in the form of a truncated pyramid, which touch suitable counter-contact points or surfaces in the device for receiving at least part of the biometer measuring head and bring the biometer into the desired position, which is held there in the desired position by gravity.

[0083] The arrangement according to the invention provides a docking station for a handheld biometer, allowing necessary regular device tests and calibrations to be carried out reliably and with minimal effort, particularly for very compact biometer versions and even in cases where the patient performs the measurements themselves at home. The integration of a test object into the docking station enables the biometer to be regularly tested for correct function and / or calibrated. Integrating the test object into the docking station instead of the handheld biometer also benefits its miniaturization.

Claims

Patent claims 1 . Docking station for a handheld biometer comprising a housing with a device for receiving at least a part of the biometer, characterized in that the device for receiving a part of the biometer is designed to receive the measuring head of the biometer and that a test object for regularly performing functional tests and / or calibrations is additionally present in the housing.

2. Docking station according to claim 1, characterized in that the test object is designed so that it is located directly in front of the measuring head of the biometer accommodated in the device of the housing or can be brought into this position.

3. Docking station according to claim 2, characterized in that the test object is designed to be configurable and / or positionable.

4. Docking station according to claim 1, characterized in that a contact sensor is present on the biometer and / or on the docking station, which signals the insertion of the biometer into the docking station.

5. Docking station according to claim 4, characterized in that both the biometer and the housing have devices which are designed to establish connections between the biometer and a control unit located in the docking station when the biometer is accommodated in the housing.

6. Docking station according to claim 1, characterized in that the docking station has a trigger which manually activates a measuring function of the biometer in the state of the biometer accommodated in the housing or automatically activated to perform regular functional tests and / or calibrations of the biometer.

7. Docking station according to claim 3 or 4, characterized in that the control unit and / or the biometer itself are / is designed to activate the measuring function of the biometer and to carry out regular functional tests and / or calibrations of the biometer.

8. Docking station according to claim 7, characterized in that a plan is stored in the control unit and / or in the biometer in order to trigger the functional tests and / or calibrations of the biometer regularly or as needed.

9. Docking station according to claim 8, characterized in that the plan stored in the control unit and / or in the biometer is based on predetermined intervals or activities performed.

10. Docking station according to claim 9, characterized in that predetermined intervals provide for calibrations, for example daily, weekly, monthly, quarterly, half-yearly or yearly or similar, or are based on the number of uses of the biometer.

11. Docking station according to claim 7, characterized in that the activities performed can be, for example, switching on the biometer, inserting the biometer into the receiving device, the approach of the operator or similar activities.

12. Docking station according to claim 5, characterized in that the control unit has an interface for transmitting data to an external device.

13. Docking station according to claim 1, characterized in that a charging station for charging a battery present in the biometer is provided in the housing.

14. Docking station according to claim 1, characterized in that the housing has a device for receiving a binocular biometer and that at least one test object is present in the housing, which is located directly in front of one of the two measuring heads of the biometer or can be brought into this position.

15. Docking station according to claim 14, characterized in that two test objects are present in the housing, which are located directly in front of the two measuring heads.

16. Docking station according to claim 1, characterized in that the biometer is a tonometer and the test object is a test eye simulating the cornea of ​​the eye.

17. Docking station according to claim 16, characterized in that the test eye is designed to be pressure-adjustable and is connected to a pressure source which has a connection to the control unit.

18. Docking station according to claim 17, characterized in that the test eye has a pressure sensor which is connected to the control unit.

19. Docking station according to claim 16, characterized in that the measuring axis of the biometer is perpendicular through the apex of the cornea replica of the test eye.

20. Docking station according to claim 1, characterized in that the housing has a dust protection device for protecting the test object when the biometer is not accommodated in the docking station.

21. Docking station according to claim 1, characterized in that the device for receiving at least a part of the biometer is designed to position the measuring head of the biometer within a tolerance of less than + / - 1 mm, in particular less than + / - 0.25 mm, relative to the test object.

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