WEARABLE AND NON-CONTACT INTRAOCULAR PRESSURE (IOP) MEASUREMENT AND MONITORING SYSTEM

20230380685 · 2023-11-30

Assignee

Inventors

Cpc classification

International classification

Abstract

A system and method for non-invasively and continuously measuring an intraocular pressure, includes a wearable device designed to be worn by a user and forms an air chamber between the wearable device and the eyes of the user. The wearable device includes flexible materials to seal the air chamber around eye cavities of the user and further includes imaging sensors for collecting 2D and 3D data of the user's eyes; a pressure controller to modify an air pressure inside the air chamber with an air pump, wherein the pressure controller can be either embedded on the wearable device or is connected to the wearable device through a flexible pressure pipe; and a central controller for constructing a model of the user's eyes using 3D imaging techniques based on the collected 2D and 3D data and output intraocular pressure calculations based on the model.

Claims

1. A system for measuring intraocular pressure, comprises: a wearable device configured to be worn by a user and forms an air chamber between the wearable device and both eyes of the user; the wearable device includes flexible material around edges to seal the air chamber around eye cavities of the user; the wearable device further includes imaging sensors for collecting 2D and 3D data of the user's eyes; a pressure controller configured to control an air pump to modify an air pressure inside the air chamber; wherein the pressure controller is embedded on the wearable device or is connected to the wearable device through a flexible pressure pipe; and a central controller including a processor and a memory, the memory stores a computer readable instruction, and when the computer readable instruction is executed by the processor, causes the central controller to construct a model of the user's eyes using 3D imaging techniques based on the collected 2D and 3D data and outputs an intraocular pressure reading based on the model.

2. The system according to claim 1, wherein the imaging sensors include at least one of: stereo imaging sensors, light detecting sensors, temperature detecting sensors, acoustic sensors, electro optic sensors, lidar sensors, pressure sensors, a force sensor, a position sensor, ultraviolet sensors, and piezo crystals for ultrasonic topography.

3. The system according to claim 1, wherein the wearable device further includes at least one of: a light emitting diode, an ultraviolet light source, a laser scanning device, a display screen for virtual reality, a display screen for augmented reality, and a scheimpflug camera.

4. The system according to claim 1, wherein the central controller further records varying air pressure data by the pressure controller and associates the collected 2D and 3D data by the wearable device to the varying air pressure data.

5. The system according to claim 1, wherein the imaging sensors continuously collects the 2D and 3D data and the central controller continuously outputs intraocular pressure readings.

6. The system according to claim 1, wherein positions and orientations of the imaging sensors are fixed or adjustable sensors.

7. The system according to claim 1, wherein the pressure controller increases and decreases the air pressure during the collecting 2D and 3D data and during collecting data coming from all embedded sensors.

8. The system according to claim 1, wherein the 2D and 3D data includes physical parameters of the user, wherein the physical parameters include at least one of: a cornea diameter, a cornea shape, a color difference, a color change, heat changes, a viscosity of a cornea, an iris shape, and an iris diameter change.

9. The system according to claim 1, wherein the central controller is further configured to determine at least one of: biomechanics of a frontal segment, a physical difference of an eye globe, a conjunctiva, sclera, or cornea under varying pressure, and a reaction of the eye globe, conjunctiva, sclera, or cornea under varying pressure.

10. The system according to claim 1, wherein the central controller is configured to separate the collected 2D and 3D data into left eye data and right eye data; and the central controller is further configured to determine the differences between the two eyes based on the left eye data and the right eye data.

11. The system according to claim 1, wherein the wearable device further includes a display screen, and the display screen provides instructions comprising a guide for guiding the user's eyes to a specific position.

12. The system according to claim 1, wherein the central controller further outputs at least one of: an intracranial pressure, a translaminar pressure gradient, a central retinal artery pressure, and an ocular perfusion pressure by measuring and calculating an ocular pulsation amplitude and period under varying external pressure.

13. The system according to claim 1, wherein the 2D and 3D data are stored in the pressure control unit or the wearable device, and the 2D and 3D data is used to calculate and estimate the intraocular pressure.

14. A system for measuring intraocular pressure, comprises: a monitoring device configured to collect 2D and 3D data from a user's eyes without an air chamber; the monitoring device is further configured to wirelessly communicate with a wearable device and obtain 2D and 3D data collected from the wearable device as reference data; wherein the monitoring device is a dedicated wearable hardware or a smart electronic device embedded with 3D imaging technology.

15. A method for measuring intraocular pressure, comprises: forming an air chamber between a wearable device and both eyes of a user; the wearable device includes flexible material around edges to seal the air chamber around eye cavities of the user; the wearable device further includes imaging sensors for collecting 2D and 3D data of the user's eyes; controlling, by a pressure controller, an air pump to modify an air pressure inside the air chamber; wherein the pressure controller is embedded on the wearable device or is connected to the wearable device through a flexible pressure pipe; and constructing, by a central controller, a model of the user's eyes using 3D imaging techniques based on the collected 2D and 3D data and outputting an intraocular pressure reading based on the model.

16. The method according to claim 15, wherein the imaging sensors include at least one of: stereo imaging sensors, light detecting sensors, temperature detecting sensors, acoustic sensors, electro optic sensors, lidar sensors, pressure sensors, a force sensor, a position sensor, ultraviolet sensors, and piezo crystals for ultrasonic topography.

17. The method according to claim 15, wherein the wearable device further includes at least one of: a light emitting diode, an ultraviolet light source, a laser scanning device, a display screen for virtual reality, a display screen for augmented reality, and a scheimpflug camera.

18. The method according to claim 15, wherein the 2D and 3D data includes physical parameters of the user, wherein the physical parameters include at least one of: a cornea diameter, a cornea shape, a color difference, a color change, heat changes, a viscosity of a cornea, an iris shape, and an iris diameter change.

19. The method according to claim 15, wherein the central controller is further configured to determine at least one of: biomechanics of a frontal segment, a physical difference of an eye globe, a conjunctiva, sclera, or cornea under varying pressure, and a reaction of the eye globe, conjunctiva, sclera, or cornea under varying pressure.

20. A non-transitory computer readable medium storing computer readable instructions, wherein when the computer readable instructions are executed by at least one processor, cause the at least one processor to perform the method according to claim 15.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In the drawings, various embodiments of the present systems and methods are illustrated by way of example. It is to be expressly understood that the description and drawings are only for the purpose of illustration.

[0049] FIG. 1 illustrates a main wearable device for measuring intraocular pressure under varying external pressure.

[0050] FIG. 2 illustrates a front view of the main wearable device with a pressure control system.

[0051] FIG. 3 illustrates a side view of the main wearable device with a pressure control system.

[0052] FIG. 4 illustrates a pressure control unit embedded on the main wearable device.

[0053] FIG. 5 illustrates the head band and flexible sealing material on the main wearable device.

[0054] FIG. 6 illustrates a front, top, and side view of the main wearable device.

[0055] FIG. 7 illustrates an internal view of the main wearable device.

[0056] FIG. 8 illustrates a monitoring device without external pressure control.

[0057] FIG. 9 illustrates an internal view of the monitoring device having sensor and excitation components on the monitoring device.

[0058] FIG. 10 illustrates another alternative for the monitoring device.

[0059] FIG. 11 illustrates another alternative for daily measurements using a smart device that is already in possession of the patient.

[0060] FIG. 12 illustrates a potential use case of the disclosed intraocular pressure measurement and monitoring system.

[0061] FIG. 13 illustrates the shapes of the cornea and eye globe shape under varying pressure.

[0062] FIG. 14 illustrates an example graph of the external pressure and cornea/sclera diameter.

[0063] FIG. 15 illustrates an exemplary ocular pulsation of a user.

DETAILED DESCRIPTION

[0064] The invention describes a new wearable tonometry device that is used to measure the intraocular pressure. This device observes the variations on the cornea and the eye globe under varying pressure conditions and measures the intraocular pressure. The working principle of the device is based on the mechanical effect of the intraocular pressure on the eye globe.

[0065] In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the invention. It is apparent, however, to one skilled in the art that the embodiments of the invention may be practiced without these specific details or with an equivalent arrangement.

[0066] The instant invention combines the advantages of the continuous IOP monitoring and the benefits of non-contact tonometry. The instant invention brings a new type of tonometry to the industry—pressure varying non-contact wearable tonometry. The invention is a wearable and easy-to-use device in a home environment for individual users to perform IOP measurements. Furthermore, the invention is portable and does not require the use of eye drops. Thus, the invention is particularly suitable for children and non-cooperative patients.

[0067] FIGS. 1-3 illustrates front and side views of a system for measuring intraocular pressure in one embodiment of the instant invention. The system includes a main wearable device 1 configured to be worn by a user and forms an air chamber between the main wearable device 1 and both eyes of the user. The main wearable device 1 includes a mini notification screen 4, notification LEDs 5, an on/off switch 8, and flexible material (shown later in FIG. 5) around the edges to seal the air chamber around eye cavities of the user. The main wearable device 1 further includes imaging sensors (shown later in FIG. 7) for collecting 2D and 3D data of the user's eyes. The 2D and 3D data includes physical parameters of the user, including, but is not limited to, the cornea diameter, cornea shape, color difference, color change, heat changes, viscosity of the cornea, iris shape, and iris diameter change. The main wearable device 1 is further connected with a pressure controller 2 for controlling an air pump 2a to modify an air pressure inside the air chamber. As shown in FIGS. 1-3, the pressure controller 2 is connected to the main wearable device 1 through a flexible pressure pipe 3. FIG. 4 illustrates another embodiment that the pressure controller 2 is embedded on the main wearable device 1. The pressure controller controls an air pump 2a to increase and decrease an air pressure inside the air chamber.

[0068] The system for measuring intraocular pressure further includes a central controller 2b in the pressure controller 2. The central controller 2b comprises a processor and a memory, the memory stores a computer readable instruction, and when the computer readable instruction is executed by the processor, causes the central controller 2b to construct a model of the user's eyes using 3D imaging techniques based on the collected 2D and 3D data and output an intraocular pressure reading based on the model. The 3D imaging techniques include, but are not limited to, Stereo imaging, Lidar, RGBD cameras, laser scanners, and time of flight sensors. In one embodiment, at least two of the above 3D imaging techniques are implemented, so that data coming from different types of sensors will be aggregated and analyzed to form high resolution 3D structure of the eyes.

[0069] The 2D and 3D data can be the image of the eye coming from a camera, or two-dimensional data coming from temperature sensors, stereo imaging sensors, light detecting sensors, temperature detecting sensors, acoustic sensors, electro optic sensors, lidar sensors, pressure sensors, a force sensor, a position sensor, ultraviolet sensors, and piezo crystals for ultrasonic topography. The 2D data defines the surfaces of the eyes for 3D reconstruction of the eyes, and the 3D data defines the shape of the eye. Under different pressure conditions, the 3D shape of the eye will be measured. The aggregated and analyzed data including and merging the data coming from various sensors will be used to calculate the intraocular pressure. Based on the 2D and 3D data, the central controller 2b is designed to calculate biomechanics of a frontal segment, a physical difference of the eye globe, conjunctiva, sclera, or cornea under varying pressure, and a reaction of the eye globe, conjunctiva, sclera, or cornea under varying pressure. The central controller 2b further separates the collected 2D and 3D data into left eye data and right eye data. The central controller 2b then calculates differences of a variety of parameters between the two eyes based on the left eye data and the right eye data. In one embodiment, the central controller 2b is embedded inside the main wearable device 1 (i.e. inside a frame of the main wearable device). In another embodiment, the central controller 2b is implemented as a server communicating wirelessly with the main wearable device 1.

[0070] FIG. 5 shows an adjustable head band 20 to fix the main wearable device 1 to a user's head and flexible sealing material 21 to seal the air chamber around eyes to enable pressure control of the instant invention. FIG. 6 illustrates a front, top, and side view of the main wearable device 1, including the mini notification screen 4, two notification LEDs 5, the on/off switch 8, and a pressure pipe outlet 9. The mini notification screen 4 allows the main wearable device 1 to show a most current intraocular pressure reading of the user. The two notification LEDs 5 are designed to indicate on, off, measuring, error states of the main wearable device 1. For example, a green light can be used to show the main wearable device 1 is powered on, no light can mean the main wearable device 1 is powered off, a blinking green light can show the main wearable device 1 is currently performing measurements, and a blinking red light can indicate the main wearable device 1 is in an error state. In another embodiment, other LED light schemes can be used to identify the various different operation states of the main wearable device 1. Furthermore, the pressure pipe outlet 9 is an air outlet connecting the air chamber to the pressure controller 2 with the flexible pressure pipe 3.

[0071] FIG. 7 illustrates the inside view of the main wearable device 1. As shown in FIG. 7, the main wearable device 1 includes the pressure pipe outlet 9 as discussed above, a stimulator array 10, a receiver sensor array 11, pressure sensors 12, a display 13, and a pressure inlet controller 14. The stimulator array 10 are sources that include, but are not limited to, LEDs, light, heat, sound, electric, scanner, infrared, and ultraviolet sources. The emissions of the stimulator array 10 is controlled by the central controller 2b. The receiver sensor array 11 are sensors for detecting a various aspect of the user's eyes, including, but are not limited to scheimpflug cameras, stereo imaging sensors, light detecting sensors, temperature detecting sensors, acoustic sensors, electro optic sensors, lidar sensors, pressure sensors, a force sensor, a position sensor, ultraviolet sensors, and piezo crystals for ultrasonic topography. The data collected by the receiver sensor array 11 is transmitted to the central controller 2b for further processing. The pressure sensors 12 are functioned to sense the air pressure inside the air chamber. Readings by the pressure sensors 12 are transmitted to the pressure controller 2 for reflecting a current air pressure inside the air chamber. All components can be fixed and/or change their positions and orientations in the device to take different measurements from different positions or different angles. The position and orientation of each element of the stimulator array 10, the receiver sensor array 11, and the pressure sensors 12 are adjustable by the user to take different measurements from different positions or different angles. The display 13 of the main wearable device 1 allows showing of virtual reality (VR) content, augmented reality (AR) content, or instructions to guide the user's eyes for focusing on specific points, thereby increasing the accuracy of the measurements. Moreover, the pressure inlet controller 14 enables the user to manually open, close, and adjust the pressure inlet.

[0072] FIG. 8 illustrates another embodiment of the instant invention. A lightweight monitoring device 19 is configured to collect 2D and 3D data from the user's eyes without the air chamber. As shown in FIG. 8, the monitoring device 19 has outer appearance as a dedicated eyeglass. The monitoring device is further configured to wirelessly communicate with the main wearable device and obtain the 2D and 3D data collected from the main wearable device as reference data. FIG. 9 illustrates the inside of the monitoring device 19, which includes a stimulator array 10 and a receiver sensor array 11 for collecting 2D and 3D data from the user's eyes. Thus, a user can use the main wearable device 1 once every period (i.e. every day, every week, or every month, etc.) to obtain an IOP measurement periodically. Between each periodic measurement using the main wearable device 1, the user can use the monitoring device 19 to collect 3D images and data of the eye globe and cornea, and continue estimating IOP readings by comparing the IOP to the reference data previously taken by the main wearable device 1. FIG. 10 shows an alternative design of the monitoring device 19. A stimulator array 10 and a receiver sensor array 11 are positioned on the frame of the eyeglass, so that the arrays 10 and 11 would not block the user's sight, thereby enabling long-term wearing the monitoring device 19 for automatically and continuously monitoring of the intraocular pressure of the user's eyes. FIG. 11 illustrates another alternative for the monitoring device 19. Instead of using monitoring devices in the shape eyeglasses, users can use their smart device sensors 18 to collect data (i.e. using the camera on the user's phone to take images) from their eye globes and transmit the collected data to the central controller 2b for calculation and estimation of the intraocular pressure based on a previously recorded reference data via the main wearable device 1.

[0073] FIG. 12 illustrates a potential use case of the intraocular pressure measurement and monitoring system of the instant invention. A patient, a medical doctor, and a hospital/clinic are connected to a cloud server in a network. The patient periodically (once a day or once a week) takes a measurement of the IOP via the main wearable device 1 (i.e. main device). The measurement process via the main wearable device includes (1) the patient wears the main wearable device, (2) the image collection starts, (3) negative pressure is initialized, (4) negative pressure is removed and the user's cornea is returned to its original position, (5) positive pressure is initialized, (6) positive pressure is removed and the user's cornea is returned to its original position, (7) the image collection ends and the collected image data is processed to obtain an IOP reading. The collected image data and IOP reading are indicated as reference data and are further transmitted to the cloud server accessible to the patient, the medical doctor, and the hospital/clinic. Once the patient has reference data store on the cloud server, the patient can choose to take another measurement of IOP using the monitoring device as shown in FIGS. 8-11. The measurement process via the monitoring device includes (1) the patient wears the light wearable glasses of FIGS. 8-10 or uses a smart device camera to capture 2D and 3D image of the eye as shown in FIG. 11, (2) if the wearable glasses of FIGS. 8-10 are used, the 3D images are captured from the patient's eyes periodically, such as every 5 minutes, and (3) the captured images are compared with the previously taken reference data to calculate and generate an current IOP reading. The IOP reading(s) is/are marked by the date and time of taking the measurement and is/are transmitted to the cloud server accessible to the patient, the medical doctor, and the hospital/clinic.

[0074] FIG. 13 illustrates the shapes of the cornea and eye globe shape under varying pressure, including air chamber 15, new eye globe shape under varying pressure 16, and new cornea shape under varying pressure 17. The left figure illustrates when positive pressure is applied in the air chamber 15, and the right figure illustrates when negative pressure is applied in the air chamber 15. D1 and D2 are the diameters of the eye globe and the cornea, respectively. Under varying external pressure, the shapes of the eye globe and cornea can be measured with 3D data collection and the diameters can be calculated. The differences between different variables are analyzed to estimate the required parameters including, but are not limited to, an intraocular pressure, an intracranial pressure, a translaminar pressure gradient, a central retinal artery pressure, and an ocular perfusion pressure by measuring and calculating the ocular pulsation amplitude and period under varying external pressure.

[0075] FIG. 14 illustrates an example graph of the external pressure and cornea/sclera diameter. To establish a relationship between the external pressure and cornea/sclera diameter, the central controller 2b further records air pressure change data by the pressure controller 2 and associates the collected 2D and 3D data by the main wearable device 1 to the air pressure change data. Once a relationship between the external pressure and cornea/sclera diameter is established for a user, the user's IOP can be estimated using this relationship.

[0076] FIG. 15 illustrates an exemplary ocular pulsation of a user. The ocular pulsation amplitude and period is further calculated based on the ocular pulsation of the user derived from the collected 2D and 3D image data and data coming from the other sensors such as pressure sensors and temperature sensors.

[0077] The monitoring device 19 as shown in FIGS. 8-10 may be, for example, a smartphone, tablet, PDA, or smartwatch having a processor, computer readable media that stores software and application programs for execution by the processor, a camera for capturing images, and a wireless communication interface for communication to a network.

[0078] The term “computer-readable media” or “computer-readable medium” as used herein refers to any media/medium that participates in providing instructions to the processor for execution. Such a medium may take many forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-volatile media may include, for example, optical or magnetic disks. Volatile media may include a dynamic memory. Transmission media may include coaxial cables, copper wire and fiber optics. Transmission media may also take the form of acoustic, optical, or electromagnetic waves, such as those generated during Radio Frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media may include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, a Compact Disc-Rewritable (CDRW), a Digital Video Disk (DVD), any other optical medium, punch cards, paper tape, optical mark sheets, any other physical medium with patterns of holes or other optically recognizable indicia, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave, or any other medium from which a computer can read.

[0079] Those skilled in the art will appreciate that the herein described systems and methods may be subject to various modifications and alternative constructions. There is no intention to limit the scope of the invention to the specific constructions described herein. Rather, the herein described systems and methods are intended to cover all modifications, alternative constructions, and equivalents falling within the scope and spirit of the invention and its equivalents.