System for Intraocular Pressure Measurement and Drug Administration to the Eye

Abstract

To provide a combination device for performing tonometrical measuring and drug application on an eye.SOLUTION: A combination device 100 for tonometrical measurement and drug application on an eye is provided, comprising: a device enclosure housing a tonometric measuring unit 101 for acquiring an intraocular pressure (IOP) measurement of the eye and a drug administration unit 113 for applying a drug to the eye; and a drug reservoir 105 attachable to the device enclosure, wherein the drug administration unit controls the withdrawal of a drug from the drug reservoir for application to the eye.SELECTED DRAWING: Figure 1A-1C

Description

Technical Field

[0001] The present invention generally relates to an ophthalmodynamometer for measuring the pressure within the eye, and more specifically to a combined device for providing intraocular pressure measurement and drug administration to the eye.

Background Art

[0002] Intraocular pressure (IOP) measurement for monitoring the pressure within the eye is of particular interest to glaucoma patients. Glaucoma or green cataract is a cupping (excavation) of the optic nerve. This typically results in a steadily progressive damage to the optic nerve and, similarly, a steady reduction in the patient's visual field. Without treatment, vision is typically completely lost. The exact cause of glaucoma or optic nerve damage has not yet been fully elucidated, but it has been identified that an increase in IOP due to deterioration of the aqueous humor drainage of the eye is likely the cause. Therefore, continuous monitoring of IOP is very important in the treatment of such patients.

[0003] Home infusion drug administration (e.g., drug administration) and intraocular pressure (IOP) measurement (e.g., ophthalmodynamometry) are, in themselves, independent modalities of glaucoma treatment. In either case, since it is typical for the patient to live with the disease until old age, continuous patient adherence and fine motor skills are required over several years. For IOP measurement, when changes in disease management are made to monitor its effectiveness, it is desirable to increase at least the frequency of regular measurements. This could have been implemented using convenient and cost-effective home monitoring methods, but even annual measurements of daily IOP fluctuations in a non-home care setting, when performed at a healthcare center (e.g., a clinic), have imposed a high cost burden.

[0004] Self-medication, particularly intravenous drug administration, has been shown to have the outcome of poor patient adherence and unsuccessful intravenous drug administration. (Along with the associated burden on the healthcare system and related efforts to introduce telemedicine and home monitoring ecosystems) The overall increase in chronic diseases is likely to increase the need for patient self-management, thereby increasing the need for vigilant and continuous patient adherence.

[0005] There are home monitoring technologies for some chronic diseases, such as self-intraocular pressure measurement (self-IOP) units (e.g., self-tonometers) for glaucoma patients. For example, the Icare (registered trademark) HOME tonometer enables IOP self-monitoring. It is designed for home use by glaucoma patients who require regular IOP monitoring as determined by an ophthalmologist. This device is based on the rebound measurement principle, where a probe (e.g., a rod) moves in and out and repeatedly bounces softly on the eyeball (e.g., the rod tip or the rebound tip is softly applied to the eyeball and bounced back) to measure the intraocular pressure. This is a portable device that patients can use to perform IOP measurements themselves at any time and does not require eye drops or a pressurized air source or other special devices or techniques. This enables out-of-hospital IOP monitoring, providing more information to the ophthalmologist and bringing comfort to the patient. For details of the Icare (registered trademark) HOME tonometer, refer to the Internet home web page of Icare Finland under Revenio Group Corporation, which is listed on the Helsinki Stock Exchange.

[0006] Alternative concepts for IOP home measurements, as described in Patent Document 1, have been proposed. This patent describes a non-contact tonometer that measures the intraocular pressure of the eye by projecting light into the eye and measuring the reflected light affected by mechanical strain. The cornea is deformed by sending a pulse of air pressure. The tonometer mainly consists of an electro-optical unit and a control unit that can be worn on the user's head. The control unit of the tonometer includes a display and, optionally, a buzzer that warns the user audibly in case of measurement failure or low battery. The electro-optical unit uses a tubular waveguide, a photodetector, and a reflector that deflects the light beam to the eye and removes a part of the reflected light that reaches the detector. The alignment of the tonometer with respect to the user's head is optionally assisted by a reticle to be observed.

[0007] Another approach for non-contact tonometry is provided in Patent Document 2, which uses a source that generates mechanical waves of several frequencies from a distance from the eye. The source may be an electromagnetic source, such as a laser source, or an acoustic source. Then, a detector, such as an optical interferometer, detects at least one surface wave from a distance from the eye and can be used to determine pressure information, for example, by using a mode map (e.g., a frequency velocity chart of a traveling wave) based on the intraocular pressure.

[0008] Methods for monitoring glaucoma treatment adherence are also known. For example, Patent Document 3 describes an ophthalmic fluid delivery device configured to deliver a nebulized ophthalmic fluid to the eye region of a patient. The ophthalmic fluid delivery device includes a nozzle having an opening through which the ophthalmic fluid can flow out, and at least one shutter disposed adjacent to the opening of the nozzle. The shutter is attached to move relative to the opening of the nozzle between an open position where the ophthalmic fluid can flow through the opening of the nozzle and a closed position where the opening is at least partially covered. A shutter actuator is disposed adjacent to the shutter and coupled to the shutter such that, by the operation of the shutter actuator, the shutter moves between the open position and the closed position.

[0009] The concept of digital drug administration and monitoring based on piezo technology is also known. For example, Patent Document 4 describes a solution for delivering a drug to the eye of a patient in need of the drug. This method may include (a) providing droplets containing a drug having a specific average size and average initial release rate, and (b) delivering the drug to the eye such that the percentage of the released mass of the droplets is delivered to the eye.

[0010] Patent Document 5 describes a portable drug dispenser including one or more chambers for holding a plurality of individually housed pharmaceuticals, a dispensing mechanism for accurately dispensing one or more individually housed pharmaceuticals when the dispensing mechanism is actuated at a specified dosage (e.g., specified amount / drop number) at a specified time, and a processor configured to determine time and other possible information such as, for example, location, patient variables, user data input for each actuation of the dispensing mechanism. The portable drug dispenser may further transmit the determined activation time to a computer located at a location remote from the dispenser, or optionally store the information on the device for reading by a clinician managing the patient. The user may also provide data inputs such as intraocular pressure, vision and other visual measurements, vital signs measured by an external measuring device, where the external measuring device includes, for example, a device wearable by the patient that measures heart rate, blood pressure and / or activity, and further may include data obtained from an optional built-in accelerometer or a sensor within another network device that communicates with a mobile phone or the dispenser.

[0011] An object of the present invention is to provide a solution that combines both home care modalities (self-medication and IOP measurement) in a specific simple process step.

[0012] Another object of the present invention is that a specific simple process is customizable as needed (i.e., pressure measurement only, or medication only, or both).

Prior Art Documents

Patent Document

[0013]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

[0014] The above object is achieved by a tonometer incorporating a drug dispensing unit. That is, a combination of a tonometer and a drug dispenser is provided. According to the present invention, any intraocular pressure measurement technique can incorporate drug administration (e.g., instillation) for administering a glaucoma treatment drug. The drug dispensing unit is a separate unit integrated with the tonometer (separated from the intraocular pressure measurement unit within the tonometer housing) and can administer the drug separately from the performance of intraocular pressure measurement. Alternatively, the drug dispensing unit can be fully integrated with the tonometer and utilize the intraocular pressure measurement unit. That is, the drug dispensing unit can utilize the pressure detection mechanism of the tonometer to administer the drug to the eye. For example, in the case of a rebound tonometer that repeatedly probes (e.g., touches) the eye using a mechanical probe (e.g., a rod tip or a rebound tip), after (or optionally) the intraocular pressure measurement is completed, the drug is applied to the same tip of the probe, and the drug can be administered to the eye when the probe contacts the eye. As another example, in the case of an air puff tonometer, the drug can be sprayed by the same air puff (or the same air puff mechanism) used to perform the intraocular pressure measurement. Thus, the drug can be administered alone in a specific independent process step, and the intraocular pressure measurement can be performed separately in another independent process step, or both the drug administration and the intraocular pressure measurement can be performed together in a specific combined step. This specific combined step may involve the drug being administered while the intraocular pressure measurement is being performed, or the combined step may consist of two sub-steps that are executed sequentially. For example, in the first sub-step, one operation (e.g., intraocular pressure measurement) is performed, and immediately thereafter, the other subset (drug administration) is performed, both being performed in response to a single measurement and drug command / sequence.

[0015] Examples of the use of rebound intraocular pressure measurement and air puff intraocular pressure measurement are provided, but it should be understood that the present invention can also be applied to other methods of tonometers such as optical coherence elastography (OCE). Thus, the present invention is intended to incorporate drug administration / distribution into OCE.

[0016] The present invention also provides a plurality of home care intraocular pressure measurement options for administering glaucoma therapeutics. Such options may include a disposable one-way pressure / drug probe for drug administration, or a license fee model for a smart cartridge that can be used via a license key for a cartridge related to a combination of the tonometer and drug dispenser of the present invention. An important aspect of the present invention is the ability to guide a patient's treatment and the ability to monitor drug and / or IOP pressure measurements in home care. This can be achieved by two-way real-time or near real-time data transfer between the patient and a responsible healthcare provider and / or third party.

[0017] A more complete understanding of the present invention, along with other objects and attainments, will become apparent and be recognized by referring to the following description and claims in conjunction with the accompanying drawings. All references mentioned in this description are hereby incorporated by reference in their entirety.

[0018] The embodiments disclosed herein are merely examples and the scope of the present disclosure is not limited thereto. Any feature described in a particular claim category, e.g., a method, can be similarly claimed in another particular claim category, e.g., a system. The dependencies or citations in the appended claims are selected for formal reasons only. However, since the subject matter resulting from intentionally citing a preceding claim can also be similarly claimed, any combination of claims and their features is disclosed and can be claimed regardless of the dependencies selected in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In the drawings, like reference symbols / characters refer to like components.

FIG. 1A-1C

FIG. 2

FIG. 3

FIG. 4

FIG. 5

FIG. 6

FIG. 7

FIG. 8A

FIG. 8B

FIG. 9

FIG. 10

FIG. 11

FIG. 12

FIG. 13

FIG. 14

DETAILED DESCRIPTION OF THE INVENTION

[0020] The present invention incorporates a drug dispensing unit (drug dispenser) into an intraocular pressure measurement unit (for example, a unit used to measure intraocular pressure, i.e., the pressure inside the eye). The intraocular pressure measurement unit may be based on any well-known intraocular pressure measurement technique such as a rebound-based tonometer, an air puff tonometer, a mechanical wave tonometer based on electromagnetic or acoustic waves, optical coherence elastography (OCE), etc. By way of example and not limitation, the present invention is described below as being applicable to a rebound-based tonometer and an air puff tonometer. The incorporated drug dispensing unit may be independent of the intraocular pressure measurement unit / mechanism of the tonometer or may incorporate a part of the intraocular pressure measurement unit / mechanism (for example, may be integrated with the intraocular pressure measurement unit). That is, the drug dispensing unit may utilize the intraocular pressure measurement mechanism to administer a drug in a predetermined dosage. For illustrative purposes, a plurality of additional examples of a rebound-based tonometer and an air puff tonometer are provided below, each shown separately with an integrated medication application dispenser and an incorporated but independent medication application dispenser.

[0021] First, the case of a rebound tonometer having an intraocular pressure measurement mechanism integrated with a drug dispensing unit will be taken up. More specifically, the first example provides a combined device for intraocular pressure measurement and drug administration to the eye. FIG. 1A shows the tip (e.g., the administration side) of an exemplary rebound tonometer 100, which uses a rebound intraocular pressure measurement probe 102 that vibrates back and forth against the cornea 119 of the eye to obtain a measurement of the intraocular pressure (IOP) of the eye. The intraocular pressure measurement probe 102 may be disposable / replaceable and typically consists of a rod 103 and a tip 104 of the tonometer. In this example, the rod 103 and tip 104 of the tonometer are used as an integral part of the drug administration / delivery unit 113 to administer the drug to the cornea 119. The rebound tonometer 100 includes a rebound tonometer mechanism as a measurement unit 101, which includes a rebound intraocular pressure measurement probe 102 (e.g., rod 103 and a rebound tip 104), an alignment unit 107 for aligning the rebound intraocular pressure measurement probe with the eye, at least one user-activated trigger (e.g., control button 109, i.e., a switch, touch screen, or optical sensor) for initiating intraocular pressure measurement and / or drug administration, and a control unit 111 (including a data storage unit 120 and a communication unit 121) for interfacing with (e.g., controlling) various units. The alignment unit 107 properly positions the rebound tonometer 100 and helps establish a predetermined distance between the measurement unit 101 and the patient's eye. The alignment unit 107 may include a concave mirror for the patient to view for self-alignment, a camera, a guiding arm extending and contacting a predetermined one or more regions of the patient's face (e.g., the forehead and / or cheeks), a distance sensor based on electromagnetic waves, etc. The data storage unit 120 may store IOP measurement values, multiple times when the drug was applied, the dosage of the administered drug, and / or one or more treatment plans provided by a physician having multiple predetermined times and dosages related to IOP measurement and drug administration.Optionally, the data storage unit 120 may be integrated with the communication unit 121 and / or may be distributed across multiple memory spaces. The communication unit 121 supports both wired and wireless communication and may provide communication links with various electronic devices such as smartphones, tablet computers, personal computers, portable (e.g., flash or thumb) memories, etc. The communication unit 121 may transfer data stored in the storage unit 120 to any of these electronic devices (e.g., for presentation or transmission to a healthcare provider or database), or may receive data for updating the storage unit 120 (e.g., updating a treatment plan). In this embodiment, the drug administration unit 113 is an integral part of the intraocular pressure measuring mechanism. For example, the drug administration unit 113 may include a single dose fluid cartridge 105 having a drug (such as a glaucoma treatment drug) housed therein within the rod 103 of the tonometer. The rebound tonometer 100 reads the intraocular pressure measurement value and administers the drug dose (simultaneously or sequentially) in response to a single input command (e.g., button 109). Optionally, two control buttons (e.g., button 109 and an optional second button 110) may be provided for separate triggers for intraocular pressure measurement and drug administration, respectively. In a typical (e.g., dynamic or contact) rebound tonometer, analysis of the movement parameters of the bouncing tonometry probe 102 after contact with the cornea 119 (by, e.g., the control unit 111, etc.) is applied to determine the IOP measurement value. Optionally, this analysis may be extended to take into account the single dose fluid cartridge 105 within the rod 103 of the tonometer. If desired, when the drug is administered while the intraocular pressure measurement value is being acquired, the movement analysis may further take into account the delivery of the drug from the single dose fluid cartridge 105 to the eye via the chip 104 while the intraocular pressure measurement value is being acquired.

[0022] In summary, a rebound tonometer 100 is proposed in the specification that houses a single-dose cartridge 105 containing an anti-glaucoma agent within the rod 103 (or tip 104) of a tonometer probe / plunger 102. FIG. 1A shows the tip of the rebound tonometer 100, with a single-dose anti-glaucoma agent 105 within its rod 103, shown together with a mechanism for separately applying intraocular pressure measurement and the agent in a single process step. Using a single-dose or unit-dose drug cartridge has the advantage that a preservative-free drug can be used. Similar to standard rebound intraocular pressure measurement, the intraocular pressure measurement probe / plunger 102 is sealed in a sterile manner. Similarly, the single-dose agent 105 is placed and sealed within the rod 103 (or tip 104) of the intraocular pressure measurement probe / plunger 102. Depending on the measurement mode of the device 100 (i.e., intraocular pressure measurement or drug administration, or both), different mechanisms are applied, resulting in a single simple process step.

[0023] FIGS. 1B and 1C show exemplary implementations of a drug delivery mechanism suitable for the tonometer of FIG. 1A. After the intraocular pressure measurement probe / plunger 102 is opened and attached to the rebound tonometer device 100, an intraocular pressure measurement value can be obtained in a standard manner using a high-speed intraocular pressure measurement sequence, as indicated, for example, by the dashed arrow 116 in FIG. 1B. Immediately after the end of the high-speed intraocular pressure measurement sequence, a mechanism (e.g., pressing the fluid cartridge 105 against the piercing tip 115) automatically breaks the drug seal of the single-dose fluid cartridge 105 and can release the drug onto the surface of the rebound tip 104 (as indicated by the thick arrow 117 in FIG. 1C). At this point, the drug is released onto the cornea 119 by one or several additional "measurement" oscillatory movements of the rebound tip 104 that contacts the eyeball (as indicated by the shaded arrow 118 in FIG. 1C). This process step is a short extension that adds only a few milliseconds to the original intraocular pressure measurement such that it is not recognized by the user as an extra operating step. Each process step can also be executed independently by a smart scheduler concept.

[0024] In an alternative embodiment, the rebound tonometer probe 102 may include a rod and a balloon-type (e.g., bladder) tip filled with a single drug dose. Although the tonometer measurement could still be performed in a standard manner, at the last contact of the balloon-type tip with the cornea (or the last few rebound contacts), the drug-filled tip (balloon-type tip) is ruptured to moisten the eye with the drug.

[0025] Furthermore, since it is possible to load the single-dose rebound probe into a magazine, no manual steps are required to load the probe / plunger 102 into the device 100, and sterility is ensured.

[0026] As an alternative, FIG. 2 shows a rebound tonometer 200 that is housed within the tonometer housing but is separated from the intraocular pressure measurement unit 201 and includes a drug administration mechanism / unit 213. This combined device 200 for intraocular pressure measurement and drug administration to the eye may include a typical rebound tonometer mechanism (using a rebound intraocular pressure measurement probe 102 as described above with reference to the rebound intraocular pressure measurement probe 202 of FIG. 1, for example) as part of a measurement unit 201 that is separated from the drug administration unit 213. The drug administration unit 213 may use a single-dose (fluid) cartridge or a multi-dose (fluid) cartridge as a drug reservoir 205. For illustrative purposes, the rebound tonometer 200 of FIG. 2 shows a multi-dose (fluid) cartridge as the drug reservoir 205. The drug administration unit 213 may further include an administration unit 223 that may be internal to the rebound tonometer 200 to control the dose per drug administration step, such as by selecting the number of drug administration doses extracted from the reservoir 205 applied during the drug administration step. The drug administration unit 213 may further include a non-contact drug administration unit 222 that can spray the drug 218 into the eye. In this example, the tonometer 200 uses a concave mirror 207 as an alignment unit, at least one control button 209 to initiate intraocular pressure measurement and / or drug administration, a first memory space (not shown) for storing measurement values and / or drug data, and a second memory space for storing treatment plans for measurement and medication, and a control unit 211. It should be understood that both the first and second memory spaces may be integrated into a single memory unit (e.g., an electronic memory or an optical memory) or may span multiple memory units. Optionally, two control buttons (e.g., button 209 and an optional second button 210) may be provided for separate triggers for intraocular pressure measurement and drug administration, respectively, as described above.The combining device 200 may further have a visual unit 225 (e.g., an LED or an electronic display) and / or an audio unit 227 (e.g., a speaker) for prompting the corresponding vision and / or hearing of the patient to perform the planned measurement and / or drug administration. The concave mirror 207 is positioned to provide a reflection of the eye visible to the patient and to assist the patient in aligning the combining device 200 with the eye.

[0027] Furthermore, the combining device 200 may have a camera unit 229 for identifying the patient and the left and right eyes of the patient, for controlling the orientation of the combining device with respect to the eyes, and / or for controlling or determining the appropriate state of the eyes (e.g., opening or closing) for intraocular pressure measurement and drug administration. The left eye can be distinguished from the right eye by paying attention to the corners and shape of the eye. For example, identifying the caruncle (e.g., the position of the caruncle) (e.g., the corner portion of the eye closest to the nose) in the image can provide a convenient way to distinguish between the left and right eyes. This determination may be performed by a special algorithm or a machine learning model.

[0028] The combining device 200 also has a communication unit 221 based on a wired interface (e.g., for a communication cable) or a wireless interface (e.g., for a wireless network, Bluetooth communication, radio frequency identification, RFID, etc.), and transfers the data stored in the control unit 211 to a (local or remote) PC, tablet, mobile memory (e.g., portable flash memory, portable optical disk, and / or Internet-accessible online memory storage), or a smart device such as a mobile phone or smart glasses (e.g., via the Internet). The combining device 200 may further have a cleaning unit (not shown) for rinsing and / or sterilizing the combining device 200, particularly the part that comes into contact with the eye, e.g., the tip of the rebound tonometer probe 202. The cleaning unit may include, for example, a sterilizing pad, wash water, or spray. As another example, if the combining device 200 includes a cover (not shown) for housing, the cleaning and sterilizing pad, wash water, or spray is housed within the cover and comes into contact with the tip when the cover is connected to the combining device 200.

[0029] Optionally, the reservoir cartridge 205 is a smart cartridge (e.g., a cartridge having an integrated circuit (IC) 215 with a contact interface (e.g., contact pads) or a non-contact interface (e.g., RFID, Bluetooth, wireless network)) and can be managed using a separate technical mechanism (e.g., of a separate electronic control device). The smart cartridge may provide, for example, a cartridge license key.

[0030] In summary, FIG. 2 shows a rebound tonometer 200 with a separate drug delivery mechanism 213 using a smart cartridge 205. The cartridge 205 can be triggered immediately after the intraocular pressure measurement is completed. For example, by inspecting the delivery mechanism using a camera 229, it is ensured that the eye is open while the drug is being administered. In this embodiment, the drug is sprayed onto the cornea 219 of the eye (using a non-contact drug delivery unit 222) from a multi-dose cartridge 205. The cartridge 205 is triggered immediately after the intraocular pressure measurement is completed, and by inspecting the delivery mechanism using a camera 229, it is ensured that the eye is open while the drug is being administered.

[0031] Some of the functions that can be performed by the embodiments of the rebound intraocular pressure measurement of FIGS. 1 and 2 are listed in Table 1 of FIG. 9. For example, both support IOP measurement and drug delivery processes, either simultaneously or individually (e.g., sequentially). Both can provide a reminder mechanism for warning the patient about a pre-scheduled drug administration or IOP measurement process. Both provide a mechanism for selecting various drug types and various dosing options. The multi-dose cartridge embodiment of FIG. 2 supports custom dosing adjustment but does not support the single-dose cartridge of FIG. 1. Nevertheless, both embodiments provide a counter for tracking drug intake / administration, a mechanism for drug delivery, a mechanism for verifying the exact dose, a mechanism for verifying the patient ID (e.g., cartridge license ID and / or use of a camera, etc.), and a mechanism for triggering automatic drug administration while the eye is open (e.g., using a camera to monitor the open / closed state of the eye, etc.).

[0032] As shown in FIG. 3, the present invention can also be incorporated into an air puff tonometer 300 that applies air 302 to the cornea 319 of the eye and determines a measured value of intraocular pressure (IOP) based on the resulting corneal deformation amount that can be observed by a combination of a light emitter and a light detector (not shown) and / or a camera 329. An exemplary air puff tonometer 300 of the present application uses a multi-dose smart cartridge 305 for glaucoma treatment drug administration that includes a cartridge license key mechanism 306. Since a multi-dose cartridge 305 is used, the dosing unit 323 is used to control / adjust the dose for each drug administration step. As shown, the drug dispenser 313 may use a separate non-contact drug administration unit 322 combined with the air puff tonometer measurement unit 301 (e.g., spraying drug 318 into the eye). Similar to the case of the rebound tonometer 200 of FIG. 2 as described above, the air puff tonometer 300 of the present invention in FIG. 3 may include an alignment unit 307 (e.g., a concave mirror), a control unit 311, a first control button 309, an optional second control button 310, a camera unit 329, a visual unit 325 (e.g., an LED or an electronic display), and an audio unit 327 (e.g., a speaker).

[0033] Briefly, a preferred combination device 300 for intraocular pressure measurement and drug administration to the eye may include an air puff tonometer as a measurement unit 301, a drug reservoir 305, a non-contact drug administration unit 322, a concave mirror as an alignment unit 307, at least one control button 309 for initiating measurement and / or drug administration, a control unit 311 having a memory (not shown) for storing measurement values and / or drug data and a memory (not shown) for storing treatment plans for measurement and medication, and a control unit 311. The combination device 300 may further include a visual unit 325 and / or an audio unit 327 for prompting the patient to perform the planned measurement and drug administration. Further, the combination device 300 includes a camera unit 329 for identifying the patient, the left and / or right eye of the patient, controlling the orientation of the combination device 300 with respect to the eye, and / or controlling the appropriate state of the eye (e.g., opening or closing) for measurement and drug administration, and a communication unit 321 for transferring data stored in (or controlled by) the control unit 311. The communication unit 321 may be based on a wired or wireless interface to a PC, tablet, mobile memory, and even a mobile phone or smart glasses. In this embodiment, the drug reservoir 305 is a multi-dose cartridge so that an additional administration unit 323 can be used.

[0034] FIG. 4 shows a second embodiment of this configuration (e.g., an air puff tonometer 400) in which the drug reservoir is implemented as a unit dose cartridge or magazine 401 so as not to require an administration unit, similar to the embodiment of FIG. 3. All other elements are the same as those described with reference to FIG. 3 unless otherwise specified.

[0035] Figure 4 shows an air puff tonometer 400 comprising a unit dose smart cartridge 405 (e.g., for glaucoma treatment drug administration) that includes a cartridge license key mechanism 406. As shown, the drug dispenser 413 uses a non-contact drug delivery unit 422 separately and is combined with the air puff tonometer measurement unit 401.

[0036] The magazine of the multiple dose cartridge 305 (Figure 3) or the unit dose cartridge 405 (Figure 4) is combined with the air puff tonometer measurement unit 301 / 401 and the camera 329 / 429 that record drug administration to the eye. Both modalities can be performed simultaneously, sequentially, or individually in specific simple process steps.

[0037] In both of these cases, the drug is sprayed onto the cornea of the eye (using the non-contact drug delivery unit 322 / 422) from the dose of drug in the multiple dose cartridge 305 or the unit dose cartridge 405.

[0038] Some of the functions that can be performed by these two embodiments of the air puff tonometer are listed in Table 2 of FIG. 10. For example, both support IOP measurements and drug delivery processes, either simultaneously or individually (e.g., sequentially). This can be achieved by using separate drug cartridges and IOP measurement channels. Both support communication with smartphones, tablet computers, smart glasses, and / or other computing devices for two-way real-time or near real-time data transfer between healthcare providers, patients, and / or third parties. Both can provide a reminder mechanism to alert patients about pre-scheduled drug administrations or IOP measurement processes. Both provide mechanisms for selecting various drug types and various dosing options. Both embodiments provide a counter for tracking drug intake / administration, a mechanism for drug delivery, a mechanism for checking the exact dosage administered, a mechanism for checking the patient ID (e.g., using a cartridge license ID and / or the use of a camera, etc.), and a mechanism for initiating automatic drug administration while the eye is open (e.g., using a camera to monitor the open / closed state of the eye).

[0039] FIG. 5 shows an alternative embodiment of an air puff tonometer 500 that combines a non-contact drug administration unit 522 with an air puff tonometer unit 501. That is, the air puff 502 of the tonometer unit 501 of the air puff tonometer used to measure IOP is also used for drug administration by spraying a drug / drug 518 from a multiple-dose cartridge 505 (or alternatively a unit-dose cartridge) onto the cornea of the eye.

[0040] The combination device 500 of the present application for intraocular pressure measurement and drug administration to the eye may include a measurement unit 501 of an air puff tonometer, a drug reservoir 505, an administration unit 523 (if required), a concave mirror as an alignment unit 507, at least one control button 509 for starting measurement and drug administration, and a control unit 511 having a memory for storing measurement values and / or drug data and a memory for storing treatment plans for measurement and medication. The combination device 500 may further include a visual unit 525 and / or an audio unit 527 for prompting the patient to perform the planned measurement and drug administration.

[0041] Furthermore, the combination device 500 may have a camera unit 529 for identifying the patient and the patient's left and right eyes, for controlling the orientation of the combination device 500 with respect to the eye, and / or for controlling the appropriate state of the eye for measurement and drug administration. The combination device 500 may also have a communication unit 521 for transferring data stored in the control unit 511. The communication unit 521 is based on wired or wireless communication for interfacing with a personal computer, a tablet computer, a mobile memory, a mobile / smartphone, and / or smart glasses.

[0042] In this example, the drug reservoir is a multi-dose cartridge 505 so that an additional administration unit 523 is required. The multi-dose smart cartridge 505 is used for glaucoma treatment drug administration and may include a cartridge license key mechanism 506.

[0043] Alternatively, the drug reservoir may be a standard drug bottle. In this case, an additional administration unit may be required. FIG. 6 shows an alternative embodiment of an air puff tonometer 600 that uses a standard drug bottle 605 for administering glaucoma therapeutic agent 618 by application of a puff of air 602, as described above. A QR code (quick response code) 641 or other identification means (such as RFID (radio frequency identification) or barcode) can be used as an interface for the standard drug bottle 605 for glaucoma therapeutic agent administration. All other elements are the same as the other air puff tonometers described above.

[0044] In another embodiment of the present invention shown in FIG. 7, the drug reservoir is a unit dose smart cartridge 705 that does not require a dosing unit. The unit dose drug has the advantage that a drug without a preservative can be used.

[0045] FIG. 7 shows an air puff tonometer 700 comprising a unit dose smart cartridge 705 for glaucoma therapeutic agent administration that includes a cartridge license key mechanism 706. All other elements of this embodiment are the same as the air puff tonometers described above.

[0046] In the examples described above, a multi-dose cartridge (e.g., of FIG. 5), a standard drug bottle interface (e.g., of FIG. 6), or a unit dose smart cartridge with a single dose (e.g., of FIG. 7) is combined with an air puff tonometer that uses the same delivery channel for both IOP measurement and drug administration (e.g., the same air puff delivery mechanism is used for both IOP measurement and drug administration).

[0047] This can be achieved, for example, by using a drip drug release mechanism that synchronizes the air puff flow and timing to deliver an air puff for both IOP measurement and administration to the eye (either simultaneously using a single air puff or continuously using sequential air puffs). That is, the air puff process step (e.g., of an air puff type administration mechanism) can be executed, with or without drug release, for example, by using a smart scheduler application / method or mechanism.

[0048] FIG. 8A shows an alternative configuration of a single unit dose smart cartridge 805 for drug delivery to the eye. FIG. 8A shows the unit dose smart cartridge 805 when not loaded into an air puff tonometer. It should be understood that a plurality of unit dose (or single dose) cartridges can be configured (e.g., loaded) within a magazine and loaded into the tonometer as a group. The front side (e.g., the side facing the eye) of the unit dose cartridge 805 can be sealed until the drug is administered to the eye. That is, the front side can be opened by a trigger of the drug release action so that the drug is delivered to the eye. Preferably, the unit dose cartridge 805 has a thin film 850 on its back side (e.g., the opposite side of the eye). The interior of the unit dose cartridge 805 can have a structured surface configured for storage and / or release of the drug (medication). The drug can be stored within the unit dose cartridge 805, for example, on the opposite side of the thin film 850, and when an air puff (or a retractable probe / arm or other force - applying mechanism) strikes (or presses on) the thin film 850, the thin film 850 is deformed and the drug within the cartridge 805 is released (e.g., pushed and / or sprayed) from the front side of the cartridge 805 towards the eye.

[0049] FIG. 8B shows the single dose cartridge 805 of FIG. 8A in an unsealed state such that the drug is delivered to the eye by an applied force (e.g., an applied air puff). In response to a trigger for drug release processing, the single-dose cartridge is opened so that the drug can be delivered to the eye. The membrane surface side within the cartridge can be physically or chemically structured so that the drug / drug can be placed on this membrane side. The layout of the structure is configured so that optimal fluid delivery to the eye can be achieved. By having such a cartridge configuration, contact with the air channel is eliminated and sterility can be ensured. A further advantage is that this approach uses only the amount of drug solution that the eye can absorb.

[0050] Alternatively, the unit-dose cartridge 805 may have a porous or grid-structured material inside. In this case, it is necessary to open both the front and back surfaces of the cartridge 805 for use so that the drug can be delivered by an air puff.

[0051] The single-dose cartridge may be placed in a magazine or loaded into an air puff channel. During intraocular pressure measurement, for example, if the drug is not administered during the performance of intraocular pressure measurement, the empty position in the magazine may be used.

[0052] FIG. 11 shows Table 3 listing several functions supported by the above-described air puff-type tonometer that uses the same air puff channel and mechanism for both intraocular pressure measurement and drug administration. For example, these configurations support both simultaneous and individual (e.g., sequential) IOP measurement and drug delivery processes, such as by drug intake and / or use of an IOP selector. This configuration supports communication with a smartphone, tablet computer, smart glasses, and / or other computing / electronic devices for two-way real-time or near real-time data transfer between a healthcare provider, patient, and / or third party. A reminder mechanism may be provided to warn the patient about a pre-scheduled drug administration or IOP measurement process. The mechanism may be provided for selection of various drug types and various administration options. Also supported by this embodiment are a counter for tracking drug intake / administration, an inspection of drug delivery, accurate dosage inspection, patient ID inspection (e.g., using a cartridge license ID and / or a camera, etc.), and a mechanism for automatic triggering of drug administration while the eye is open (e.g., using a camera to monitor the eye opening / closing state).

[0053] In addition to housing both an intraocular pressure measurement unit (for obtaining a measurement value of the intraocular pressure (IOP) of the eye) and a drug administration unit (for administering a drug / agent to the eye), the above-described combined device further provides a mechanism (e.g., a control unit, a memory unit, a communication unit, a smartphone, a tablet computer, etc.) for monitoring drug administration adherence (e.g., treatment plan adherence) and for monitoring the effectiveness of the drug and its dosage. These mechanisms may be extended to provide additional information to the healthcare provider for better controlling the dosage and type of drugs prescribed to the patient.

[0054] FIG. 12 shows another embodiment of the combination device 1200 for tonometry and drug administration, along with an exemplary application 1272A for improved monitoring of IOP measurement values and better evaluation of drug effectiveness. In this example, the tonometer is provided within a "cap" 1280 that is attached to a drug bottle (or cartridge / drug reservoir) 1205. In this example, the drug bottle 1205 (which has an optional QR code 1241) is a standard eye drop bottle that delivers a drug as eye drop medicine 1218. The tonometer 1200 of the present application performs tonometry in a non-contact manner, thereby minimizing asepticity problems. Although it is preferred in this example to use ultrasound to obtain IOP measurement values, it should be understood that any of the non-contact methods described above may optionally be used.

[0055] In FIG. 12, one or more ultrasound transducers 1201 (or transceivers) can be disposed on (or inside) the cap 1280 such that when the cap 1280 is attached to the drug bottle 1205, the ultrasound transducer 1201 is disposed along the opening of the drug bottle 1205 (e.g., around or along the periphery of the opening). The ultrasound transducer 1201, which can be a miniaturized ultrasound transducer, converts the received control signal into a sound wave, applies a force to the cornea 1219 of the eye, and causes deformation of the cornea 1219 and / or a mechanical wave in the cornea 1219. This mechanical strain on the cornea is then observed by the tonometer 1200 (e.g., by using the above-described transceiver, camera, photodetector, interferometer, etc.) to obtain an IOP measurement value. Preferably, the tonometer 1280 is a remote computing device 1270, such as a smartphone or tablet computer, that executes a software drug management application (e.g., "Drug Management App" 1272A / 1272B), and includes a wireless communication device (e.g., RFID, Bluetooth, Wi-Fi, etc.) that communicates (bidirectionally) with the tonometer 1200 (e.g., by transferring a wireless signal). Optionally, some of the above-described multiple tasks of the tonometer according to the present invention (e.g., data processing and data storage) can be off-loaded from the tonometer 1280 to the remote computing device 1270 to reduce the number of components required for the tonometer 1280. Optionally, the remote computing device 1270 can have an attachable (or integrated) wireless energy transmitter 1274 to wirelessly power the tonometer 1200 so that the tonometer 1280 can operate without using a battery or other dedicated power source.

[0056] In this way, the tonometer 1280 effectively constitutes a non-contact and miniaturized ultrasonic intraocular pressure measurement device provided within a tonometer-cap (having an ultrasonic transducer array) for the drug delivery bottle 1205. The tonometer 1280 may be reused by transferring it from a specific bottle 1205 to another bottle. Alternatively, each eye drop bottle 1205 may be provided with its own tonometer cap (e.g., "tono cap").

[0057] Preferably, the drug management application 1272A may be configured to improve the intraocular pressure measurement values presented to the healthcare provider and evaluate the effectiveness of a specific drug. The healthcare provider typically considers only one IOP measurement per day when reviewing the patient's IOP history. However, it has been found that the information reviewed by the healthcare provider may not be optimal. Apart from the inherent error for each IOP measurement value, the patient's intraocular pressure may vary throughout the day such that one IOP measurement per day may not appropriately represent the patient's daily IOP status. Furthermore, it has been observed that the effectiveness of drugs that lower IOP may decrease over time. There may be multiple reasons for the decrease in the effect of the drug. For example, instillation drugs may cause tissue changes (e.g., conjunctival scarring, etc.) such that the tissue's response to the drug changes (e.g., decreases) over time. Another reason is that the patient may not respond at all to a specific type of action mechanism, such that the patient is a non-responder (or a limited responder) to a specific drug. Therefore, when the healthcare provider observes an upward trend in IOP, especially when the patient is taking multiple different drugs, it may not be possible to determine whether the IOP has increased because the eye's aqueous humor drainage ability has further decreased, or because the drug has become ineffective (the effectiveness has decreased). The one or more combination devices and drug management applications described above assist in addressing these issues.

[0058] Typically, a patient receives IOP measurements once a day, e.g., in the morning. However, due to changes in aqueous humor production, etc., a person's IOP can vary during the day. However, treatment of the patient may require administration of the drug multiple times a day, such as in the morning, at noon, and in the evening. A preferred embodiment can automatically perform IOP measurements each time the drug is administered. That is, an automatic IOP measurement can also be initiated by an input signal to the combination device for administering the drug. Thus, the combination device of the present application can record multiple IOP measurement values in a day, e.g., three measurement values in a day (morning, noon, evening), and combine these (e.g., by averaging) to provide a more meaningful (representative) IOP measurement value for that day to the healthcare provider. For example, each IOP measurement value may have an inherent measurement error, but by averaging multiple IOP measurement values at different times of the day, a more representative IOP measurement value for that day can be provided while reducing the overall error measurement value.

[0059] Referring to FIG. 13, one or more combination devices (and / or drug management apps 1272A / 1272B) of the present application can monitor and compare multiple IOP measurement values and multiple administered drug dosages (according to the same time reference) to determine the effectiveness of a particular drug type and dosage. The remote computing device 1270 can generate a plot of multiple intraocular pressure readings (e.g., multiple measurements) versus time for each drug administered, and a plot of drug dosage versus time for the drug administered. In this example, three plots 1273, 1275, 1277 of drug dosage versus time are shown for three different drugs Med_A, Med_B, Med_C, respectively. This information can be provided in the summary section SUM1 of the app 1272A / 1272B. This approach helps to more appropriately determine how intraocular pressure changes in the presence or absence (e.g., increase or decrease) of multiple drugs. A decrease in drug dosage can be intentional (e.g., prescribed) or unintentional (e.g., the patient misses a dose and / or administers the wrong dosage). Exemplary cases are provided to illustrate this function.

[0060] In an exemplary case, the patient initially takes only drug Med_A. If the healthcare provider observes an increase in intraocular pressure, the healthcare provider may add drug Med_B and then add a third drug Med_C to lower the IOP. Med_A, Med_B, and Med_C may have different IOP-lowering mechanisms (e.g., prostaglandins, beta blockers, etc.). As described above, drugs may lose their effectiveness over time (e.g., gradually). For example, the effectiveness of Med_A may be lost when Med_C is added, but no one notices the change in the effectiveness of Med_A, and the patient continues to take Med_A with little effect. The present invention assists in identifying these changes in the effectiveness of drugs.

[0061] For example, if the patient has previously exhausted Med_A over several days or simply forgotten to administer it, the monitoring system of the present invention that combines drug use and IOP measurement will detect that the measured IOP is not responsive to the omitted drug Med_A. That is, the omission of Med_A has a small effect on the measured IOP (e.g., within a predetermined range or percentage of the observed norm or running average). This indicates that the drug Med_A may no longer be effective for a particular patient. And the healthcare provider is notified (e.g., warned by email or summary SUM1) about this possible change in effectiveness by SUM1 or the like. And the healthcare provider may choose to exclude Med_A from the patient's treatment plan, freeing the patient from side effects such as stinging, dry eyes, redness, and eyelash growth associated with Med_A.

[0062] As another example, if the patient forgets to take Med_B later, even if the patient is still taking Med_C, there may be a significant impact on IOP (e.g., greater than an increase in a pre-defined range or percentage), which may indicate that Med_B is more effective than Med_C for a particular patient. Again, the healthcare provider is notified of the strong effect of taking (or omitting) Med_B. The healthcare provider may then choose to increase the dosage of Med_B and perhaps remove Med_C from the patient's treatment plan, which can be helpful to the patient, especially if the side effects of Med_C are stronger than those of Med_B and / or the intake of Med_C places an economic burden on the patient. This also reduces the possibility that the patient will develop resistance to Med_C (e.g., become non-responsive or a "non-responder" to Med_C).

[0063] Accordingly, the present invention can utilize happenstance to better tailor a treatment plan to a particular patient. That is, the present invention can utilize the fact that the patient sometimes forgets to take an infusion drug (or accidentally increases or decreases the dosage) and utilize the corresponding IOP response that is observed. This approach also allows the healthcare provider to intentionally change the patient's treatment plan and use the resulting observed change in IOP to modify the risk / benefit ratio of a particular drug.

[0064] As described above, the combination device of the present application can include one or more software applications 1272A / 1272B. A particular application (or application interface) 1272A may be adjusted for physician use, and another 1272B may be designed for patient use. The physician interface 1272A needs to be comprehensive, but provides a quick summary of various information, such as by using a summary section SUM1 that may include text information and plots 1271 - 1277. For example, the summary section SUM1 may include an IOP curve 1271A (e.g., a plot of the average IOP value for an individual day or the running average IOP value), a minimum - maximum band 1271B (e.g., a graphic display, plot, and / or numerical values), sliding average values, etc. The summary section SUM1 may also specify the percentage of drug use adherence for variable filter criteria such as for each type of drug, e.g., "Drug Med_A → 40% adherence", "Med_B → morning: 60% adherence", "Med_B → evening: 10% adherence", etc. The above - described IOP responses for multiple individual drugs may include in the summary, e.g., "Med_A → 75% of IOP reduction effect result or may include in the summary, e.g., "Med_B → Warning: Non - responder to drug Med_B!".

[0065] The patient app interface 1272B, in addition to providing basic instructions, needs to have a quick and direct response regarding where the patient is located and whether a particular drug administration or IOP measurement was successful. For example, for multiple time periods (morning, afternoon, evening), multiple check marks CK1 can represent the proper use of the drip medication, and / or an X1 can represent the improper use of the drip medication. Further, multiple aspects of gamification can be used to help enhance the patient's motivation to comply with the treatment plan by providing coaching feedback such as "Congratulations: With 95% medication use adherence, you belong to the top 10% of patients in your age group." Also, the adherence rate (evaluated at time intervals such as daily, weekly, monthly) can be displayed as a trend curve / plot 1271C.

[0066] FIG. 14 shows an exemplary computer system (or computing device or computer device) suitable for a remote computing device 1270 (optionally, at least a portion of the combined device configuration described above). In some embodiments, one or more computer systems provide the functions described or illustrated herein and perform one or more steps of one or more of the methods described or illustrated herein. The computer system can take any suitable physical form. For example, the computer system can be an embedded computer system, a system-on-chip (SOC), a single-board computer system (SBC) (such as a computer-on-module (COM) or a system-on-module (SOM)), a desktop computer system, a laptop or notebook computer system, a mesh of computer systems, a mobile phone, a personal digital assistant (PDA), a server, a tablet computer system, an augmented / virtual reality device, or a combination of two or more of these. Optionally, the computer system can exist in the cloud, including one or more cloud components within one or more networks.

[0067] In some embodiments, the computer system includes a processor Cpnt1, a memory Cpnt2, a storage Cpnt3, an input / output (I / O) interface Cpnt4, a communication interface Cpnt5, and a bus Cpnt6. Optionally, the computer system can include a display Cpnt7, such as a computer monitor or screen.

[0068] Processor Cpnt1 includes hardware for executing instructions such as constituting a computer program. For example, Processor Cpnt1 can be general-purpose computing on a central processing unit (CPU) or a graphics processing unit (GPGPU). Processor Cpnt1 fetches (or retrieves) instructions from internal registers, internal caches, Memory Cpnt2, or Storage Cpnt3, decodes and executes the instructions, and can write one or more results to internal registers, internal caches, Memory Cpnt2, or Storage Cpnt3. In certain embodiments, Processor Cpnt1 can include one or more internal caches for data, instructions, or addresses. Processor Cpnt1 can include one or more instruction caches and one or more data caches for holding data tables, etc. Instructions in the instruction cache can be copies of instructions in Memory Cpnt2 or Storage Cpnt3, and the instruction cache can speed up the retrieval of those instructions by Processor Cpnt1. Processor Cpnt1 can include any suitable number of internal registers and can include one or more arithmetic logic units (ALUs). Processor Cpnt1 can be a multi-core processor and can also include one or more Processor Cpnt1s. This disclosure describes and illustrates particular processors, but this disclosure contemplates any suitable processor.

[0069] Memory Cpnt2 may include a main memory for storing instructions for the processor Cpnt1 to execute or hold intermediate data during processing. For example, the computer system CS1 may load instructions or data (e.g., a data table) into the memory Cpnt2 from the storage Cpnt3 or from another source (such as another computer system CS1). The processor Cpnt1 may load instructions and data from the memory Cpnt2 into one or more internal registers or an internal cache. To execute an instruction, the processor Cpnt1 may fetch and decode the instruction from the internal register or internal cache. During or after the execution of an instruction, the processor Cpnt1 may write one or more results (which may be intermediate or final results) to an internal register, internal cache, memory Cpnt2, or storage Cpnt3. The bus Cpnt6 may include one or more memory buses (each of which may include an address bus and a data bus) and may connect the processor Cpnt1 to the memory Cpnt2 and / or the storage Cpnt3. Optionally, one or more memory management unit (MMU) functions transfer data between the processor Cpnt1 and the memory Cpnt2. The memory Cpnt2 (which may be a volatile memory that is fast) may include random access memory (RAM) such as dynamic RAM (DRAM) or static RAM (SRAM). The storage Cpnt3 may include long-term or large-capacity storage for data or instructions. The storage Cpnt3 may be internal or external to the computer system CS1 and may include one or more disk drives (e.g., a hard disk drive, HDD, or solid state drive, SSD), flash memory, ROM, EPROM, optical disk, magneto-optical disk, magnetic tape, a universal serial bus (USB)-accessible drive, or other types of non-volatile memory.

[0070] The I / O interface Cpnt4 is a combination of software, hardware, or both software and hardware, and includes one or more interfaces (e.g., serial or parallel communication ports) for communication with an I / O device that can enable communication with a person (e.g., a user). For example, the I / O device may include a keyboard, keypad, microphone, monitor, mouse, printer, scanner, speaker, steel camera, stylus, tablet, touch screen, trackball, video camera, another suitable I / O device, or a combination of two or more of these.

[0071] The communication interface Cpnt5 may provide a network interface for communicating with other systems or networks. The communication interface Cpnt5 may include a Bluetooth® interface or other types of packet-based communication. For example, the communication interface Cpnt5 may include a network interface controller (NIC) and / or a wireless NIC or wireless adapter for communicating with a wireless network. The communication interface Cpnt5 provides communication with a WI-FI network, an ad hoc network, a personal area network (PAN), a wireless PAN (e.g., a Bluetooth WPAN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a cellular phone network (e.g., a Global System for Mobile Communications (GSM®) network, etc.), the Internet, or a combination of two or more of these.

[0072] Bus Cpnt6 provides a communication link between the above components of computing system CS1. For example, Bus Cpnt6 can include an Accelerated Graphics Port (AGP) or other graphics bus, an Enhanced Industry Standard Architecture (EISA) bus, a Front Side Bus (FSB), a HyperTransport (HT) interconnect, an Industry Standard Architecture (ISA) bus, an InfiniBand bus, a Low Pin Count (LPC) bus, a memory bus, a MicroChannel Architecture (MCA) bus, a Peripheral Component Interconnect (PCI) bus, a PCI Express (PCIe) bus, a Serial Advanced Technology Attachment (SATA) bus, a Video Electronics Standards Association Local (VLB) bus, or other suitable bus, or a combination of two or more of these.

[0073] This disclosure describes and illustrates a particular computer system having a particular number of particular components in a particular device, but this disclosure contemplates any suitable computer system having any suitable number of any suitable components of any suitable device.

[0074] In this specification, a computer-readable non-transitory storage medium (singular or plural) may include one or more semiconductor-based or other integrated circuits (ICs) (e.g., field-programmable gate arrays (FPGAs) or application-specific ICs (ASICs)), hard disk drives (HDDs), hybrid hard drives (HHDs), optical disks, optical disk drives (ODDs), magneto-optical disks, magneto-optical drives, floppy disks (registered trademarks), floppy disk (registered trademark) drives (FDDs), magnetic tapes, solid-state drives (SSDs), RAM drives, secure digital cards or drives, or other suitable computer-readable non-transitory storage media, or, if necessary, any suitable combination of two or more of these. The computer-readable non-transitory storage medium may, if necessary, be volatile, non-volatile, or a combination of volatile and non-volatile.

[0075] Although the present invention has been described in connection with some specific embodiments, it will be apparent to those skilled in the art that many additional substitutions, modifications, and variations are obvious in light of the foregoing description. It is intended that the present invention as described herein encompass all such alternatives, modifications, adaptations, and variations that may fall within the spirit and scope of the appended claims. The following describes, as an appended note, the technical idea that can be grasped from the above embodiments. [Appended Note 1] A combined device for intraocular pressure measurement and drug administration to an eye, comprising: a device housing that houses an intraocular pressure (IOP) measurement unit for obtaining a measured value of the intraocular pressure of the eye and a drug administration unit for administering a drug to the eye; and a drug reservoir attachable to the device housing, wherein the drug administration unit comprises the drug reservoir and controls extracting the drug from the drug reservoir for administration to the eye. [Appended Note 2] further comprising a camera arranged to monitor the eye, and the drug administration unit automatically administers the drug to the eye in response to being determined based on the camera that the eye is in an open state, the combined device according to Appended Note 1. [Appended Note 3] further comprising a camera arranged to monitor the eye, and the control unit restricts the operation of the intraocular pressure measurement unit or the drug administration unit only when it is determined based on the camera that the eye is in an open state, the combined device according to Appended Note 1. [Appended Note 4] further comprising a camera arranged to monitor the eye, and the combined device identifies a patient based on an image from the camera, the combined device according to Appended Note 1. [Appended Note 5] further comprising a camera arranged to monitor the eye, and the combined device identifies the eye as the left eye or the right eye based on an image from the camera, the combined device according to Appended Note 1. [Appended Note 6] a camera arranged to monitor the eye when the intraocular pressure measurement unit is dynamically obtaining an IOP measurement value or when the drug administration unit is dynamically administering the drug to the eye, and a control unit that records whether the eye is open or closed based on the camera during at least one of the period when the intraocular pressure measurement unit obtains the IOP measurement value and the period when the drug administration unit administers the drug, the combined device according to Appended Note 1. [Appended Note 7] further comprising a user-operable control input, and both the intraocular pressure measurement unit and the drug administration unit respond to the same user-operable control input, the combined device according to Appended Note 1. [Appended Note 8] The combination device according to appended note 7, wherein both the intraocular pressure measurement unit and the drug administration unit are simultaneously activated in response to the same user-operable control input. [Appended note 9] The combination device according to appended note 7, wherein both the intraocular pressure measurement unit and the drug administration unit are continuously activated in response to the same user-operable control input. [Appended note 10] Drug administration is activated in response to a drug administration control input, The combination device according to appended note 1, wherein acquisition of an intraocular pressure measurement value is further automatically started by the drug administration control input. [Appended note 11] The combination device according to appended note 1, further comprising a storage unit that stores at least one of the IOP measurement value from the intraocular pressure measurement unit, the drug administration amount administered by the drug administration unit, the time when the IOP measurement value or drug is administered, and the treatment plan. [Appended note 12] The combination device according to appended note 1, further comprising a communication unit for establishing a communication link to an external electronic device and exchanging information between the combination device and the external electronic device. [Appended note 13] The combination device includes a dosage monitoring unit that acquires a measurement value of the amount of drug administered to the eye, The combination device according to appended note 12, wherein the external electronic device includes an electronic data processor that determines an effectiveness measurement value of the plurality of individual drugs based on the administered amounts of the plurality of individual drugs and the resulting monitored IOP measurement values. [Appended note 14] The combination device according to appended note 13, wherein the electronic data processor issues a warning in response to an individual drug having a determined effectiveness measure value that is less than a first predetermined threshold or exceeds a second predetermined threshold higher than the first predetermined threshold. [Appended note 15] The combination device according to appended note 13, wherein the electronic data processor determines a daily IOP measurement value by combining a plurality of IOP measurement values acquired at different times on the same day. [Appended note 16] The combination device according to appended note 13, wherein the external electronic device includes an electronic screen that displays a plot of the intraocular pressure measurement value over time or a plot of the drug administration amount over time. [Appended note 17] The combination device according to appended note 12, wherein the external electronic device is one of a personal computer, a tablet computer, a mobile memory, a mobile phone, or smart glasses. [Appended note 18] The combined device according to appendix 1, further comprising a visual display or an audio unit for communicating treatment information to the user. [Appendix 19] The combined device according to appendix 1, further comprising an alignment unit including a concave mirror for aligning at least one of the intraocular pressure measurement unit and the drug administration unit with the eye, wherein the concave mirror is arranged to provide a reflection of the eye visible to the patient during acquisition of the intraocular pressure measurement value or during administration of the drug to the eye. [Appendix 20] The intraocular pressure measurement unit is a dynamic contact intraocular pressure measurement unit that generates a mechanical response in the cornea of the eye by acting on the cornea with a mechanical probe, wherein the probe is an integral part of the drug administration unit, and the probe accesses the drug reservoir and selectively delivers the drug from the drug reservoir to the eye by acting on the eye. The combined device according to appendix 1. [Appendix 21] The combined device according to appendix 20, wherein the drug reservoir is an integral part of the probe. [Appendix 22] The combined device according to appendix 21, wherein the probe includes a puncturing mechanism for selectively puncturing the drug reservoir to extract the drug and delivering the drug to a portion of the probe that acts on the eye. [Appendix 23] The probe has a tip that acts on the cornea, wherein the drug reservoir is housed within the probe, and the drug is selectively delivered from the drug reservoir to the tip of the probe. The combined device according to appendix 20. [Appendix 24] The combined device according to appendix 20, wherein the probe includes a bladder that acts on the cornea, and the bladder is the drug reservoir. [Appendix 25] The combined device according to appendix 20, wherein the drug from the reservoir is automatically delivered to the surface of the probe when the intraocular pressure measurement unit completes acquisition of the intraocular pressure (IOP) measurement value. [Appendix 26] The intraocular pressure measurement unit is a dynamic contact intraocular pressure measurement unit that generates a mechanical response in the cornea by acting on the cornea of the eye with a mechanical probe, and the drug administration unit is a non-contact drug administration unit that ejects the drug onto the cornea of the eye. The combined device according to appendix 1. [Appendix 27] The intraocular pressure measurement unit is a non-contact intraocular pressure measurement unit including a mechanism for generating a mechanical response in the cornea of the eye by any of an applied electromagnetic wave, sound wave, or air release. The drug administration unit is a non-contact drug administration unit, and the combined device according to Supplementary Note 1. [Supplementary Note 28] The applanation tonometer unit has an air applicator opening for applying a puff of air to the eye, The drug administration unit is the combined device according to Supplementary Note 27, which sprays the drug onto the eye through the air applicator opening of the non-contact applanation tonometer unit. [Supplementary Note 29] The drug reservoir has a drug dispersion opening to which a cap can be attached, The device housing is provided in a cap that covers the drug dispersion opening of the drug reservoir, and the combined device according to Supplementary Note 1. [Supplementary Note 30] The drug reservoir is a standard drug bottle, and the combined device according to Supplementary Note 29. [Supplementary Note 31] The cap includes one or more ultrasonic transducers that cause mechanical distortion to the cornea of the eye, and the combined device according to Supplementary Note 30. [Supplementary Note 32] The applanation tonometer unit is one of a rebound tonometer, an air puff tonometer, or an optical coherence elastography (OCE) tonometer, and the combined device according to Supplementary Note 1. [Supplementary Note 33] The drug reservoir is one of a single-dose cartridge, a unit-dose cartridge, a multi-dose cartridge, or a standard medical bottle, and the combined device according to Supplementary Note 1. [Supplementary Note 34] The drug reservoir is one of a multi-dose cartridge or a standard bottle, and the combined device according to Supplementary Note 1, further comprising a dosing unit for controlling the amount of drug administered to the eye. [Supplementary Note 35] The combined device according to Supplementary Note 1, further comprising two control buttons for each separate trigger for applanation tonometer measurement and drug administration. [Supplementary Note 36] The combined device according to Supplementary Note 1, further comprising a unit for visually or audibly prompting the patient to perform scheduled measurements and drug administrations. [Supplementary Note 37] The combined device according to Supplementary Note 1, further comprising a covering unit for covering or surrounding at least a part of the combined device that comes into contact with the eye during applanation tonometer measurement or drug administration. [Supplementary Note 38] The combined device according to Supplementary Note 1, further comprising a cleaning unit for performing at least one of rinsing and sterilizing any part of the combined device that comes into contact with the eye.

Claims

1. A system, A combined device for intraocular pressure measurement and drug administration to the eye, An apparatus housing that houses an intraocular pressure measurement unit for obtaining a measured value of the intraocular pressure (IOP) of the eye and a drug administration unit for administering a drug to the eye, A drug reservoir attachable to the apparatus housing, wherein the drug administration unit controls extracting a drug from the drug reservoir for administration to the eye, the drug reservoir, A dosage monitoring unit for obtaining a measured value of the amount of drug administered to the eye, A communication unit for establishing a communication link to an external electronic device and exchanging information between the combined device and the external electronic device, The combined device including, The external electronic device including an electronic data processor, and comprising, The electronic data processor, Receives from the combined device the administered amounts of a plurality of individual drugs for drug administrations at a plurality of times and the monitored IOP measurement values as a result thereof, The external electronic device includes an electronic screen that displays a plot of IOP measurement values against time and a plot of administered amounts for the plurality of individual drugs against time, The electronic data processor, Calculates a representative value of the IOP measurement values for a preset period from the IOP measurement values for the drug administrations at the plurality of times, The plot of the IOP measurement values against time is a plot of the representative value of the IOP measurement values against time, a system.

2. The system according to claim 1, wherein the electronic data processor determines the IOP measurement value for one day by combining a plurality of IOP measurement values obtained at different times on the same day.

3. The system according to claim 1, wherein the external electronic device is one of a personal computer, a tablet computer, a mobile memory, a mobile phone, or smart glasses.

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