Patient positioning system for enhanced corneal graft attachment after ophthalmological procedure

Abstract

The present disclosure provides a solution for maintaining, by monitoring and guidance operations, a desired condition state in an eye of the subject, following an ophthalmological procedure. For example, the procedure may be corneal transplant, either a complete transplant of a corneal or a partial transplant of some layers of the cornea. Following the procedure, a gas bubble is injected into the eye to maintain the corneal graft in position. As long as the gas bubble is located below the corneal graft, it assists in maintaining the graft in position. As the gas bubble is lighter than the medium in the eye, it keeps pushing upwards and applying forces on the graft and preventing it from dislocating. The present disclosure provides a solution that keeps monitoring the gas bubble, or any other condition state resulted by an ophthalmological procedure and providing instructions to the subject in case the gas bubble deviates from certain allowed boundaries within the eye.

Description

[0001] PATIENT POSITIONING SYSTEM FOR ENHANCED CORNEAL GRAFT ATTACHMENT AFTER OPHTHALMOLOGICAL PROCEDURE

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure is in the field of post-ophthalmology surgery solutions, in particular post-endothelial keratoplasty procedure solution.

[0004] BACKGROUND ART

[0005] References considered to be relevant as background to the presently disclosed subject matter are listed below:

[0006] - US20200179642

[0007] - CN106408889

[0008] - US20110128223

[0009] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0010] BACKGROUND

[0011] The cornea is the outermost, clear layer of the eye. It consists of 5 layers (from anterior to posterior): epithelium, bowman, stroma, descemet’s membrane and endothelium and responsible for approximately two-thirds of the eye’s total optical power. Cornea transplant is an operation to replace part of the cornea with corneal tissue from a donor. Corneal endothelial transplantation has become the gold standard for the treatment of corneal endothelial dysfunctions, replacing full thickness transplantation, also known as penetrating keratoplasty. Corneal endothelial transplantation has been described using two different techniques: Descemef s membrane endothelial keratoplasty (DMAEK) and Descemet’s stripping automated endothelial keratoplasty (DSAEK). Both performed worldwide. Endothelial keratoplasty (EK) is a surgical technique performed in an operating room. During the procedure, the patient is in a prone position, a circular portion of the corneal inner layer is stripped and removed, a partial thickness donor cornea is prepared with a microkeratome and placed in the recipient’s eye, and a bubble (air for DSAEK or SF6 gas for DMAEK) of approximately 8 to 9 mm is left in the anterior chamber of the eye to stabilize the donor graft. After the surgery, the patient lays in supine position, flat, facing the ceiling during the first 2 hours, and afterwards needs to maintain this positioning as much as possible throughout the next 24 hours.

[0012] Graft detachment (whether partial or full) is the most common complication after EK surgeries. It prevents the success of the operation and visual improvement. The rate of postoperative detachment after DSAEK varies among studies with an average of 15%. Compared with DSAEK, DMAEK provides better visual recovery and reduced rejection rates, but has an increased dislocation rate of approximately 23%. Previous studies showed even higher rates of up to 34.1% in cases of DMAEK combined with cataract surgery. If a dislocated graft is observed during the post-operative stage, the patient is brought again to the operating room for a re-bubbling procedure.

[0013] Incomplete corneal graft attachment, a common complication after endothelial keratoplasty, impairs visual recovery and results in significant costs for the health system due to the need for re-bubbling at an operating room.

[0014] The bubble (air or SF6 gas) that stabilizes the donor graft during the post-operative time, hence lowering the risk for graft detachment, can only be effective if it covers the graft. The patients are instructed to maintain a supine position and to face the ceiling (as in that position the cornea is the highest area in the eyeball) as much as possible during the first 24 hours. However, any movement of the eyes, head or disconnection of the shoulders from a 180-degree bed can change the optimal position of the bubble as it is lighter compared to the anterior chamber fluid and therefore increases the chance for graft dislocation. Maintaining accurate position of the bubble is even more important in patients with anterior chamber aqueous shunts, as movement from the optimal position may lead to drainage of the entire bubble via the shunts. GENERAL DESCRIPTION

[0015] The present disclosure provides a solution for maintaining, by monitoring and guidance operations, a desired condition state in an eye of the subject, following an ophthalmological procedure. For example, the procedure may be corneal transplant, either a complete transplant of a corneal or a partial transplant of some layers of the cornea. Following the procedure, a gas bubble is injected into the eye to maintain the corneal graft in position. As long as the gas bubble is located below the corneal graft, it assists in maintaining the graft in position. As the gas bubble is lighter than the medium in the eye, it keeps pushing upwards and applying forces on the graft and preventing it from dislocating. The present disclosure provides a solution that keeps monitoring the gas bubble, or any other condition state resulted by an ophthalmological procedure. When the monitored condition state is identified to be not in a predetermined allowed state, i.e. in a non-desired state, such as a location of the gas bubble that does not cover or overlap with the corneal graft, an output is delivered to the subject that includes indication that the condition state is not in its allowed state with guidance for moving one or more body parts, e.g. moving the gaze to a certain location, rotating the head to a certain direction, and / or moving the shoulders to a certain position. By complying with the movements of one or more body parts, the condition state in the eye of the subject returns to its allowed state. Therefore, the solution of the present disclosure makes use of a monitoring system, e.g. an imaging system, for constantly monitoring the eye of the subject and therefore the condition state in the eye of the subject. Furthermore, the solution may include one or more sensors configured for monitoring the states of the body parts that affect the condition state in the eye of the subject. Typically, each body part is sensed by a dedicated sensor and when the output is delivered to the subject, it is based on the current states of the body parts. Namely, if the condition state is identified to be not in the allowed state, it is evaluated, based on the sensory inputs, what the effect of each state of different body part is to the result and the output includes guidance of moving the body parts in order to bring the condition state back to the allowed state.

[0016] For example, the solutions may include all or some of the following components:

[0017] 1. Glasses - a glasses mount, eye tracker and a camera (either as part of the eye tracker camera or as a standalone) that identify the bubble in the anterior chamber of the operated eye and the eye movements and the location of the bubble in the anterior chamber. The glasses may include a display screen (e.g., glasses lenses) providing simple and clear visual instructions, to ensure keeping the bubble in the correct position in the anterior chamber of the eye.

[0018] 2. Neck or head movement sensors - a gyroscope and accelerometer-based sensors to monitor neck or head movements.

[0019] 3. Shoulders movement sensor - touch sensors to identify the touch of patient’s shoulders with the bed.

[0020] 4. Headphones - to provide the patient with simple and clear audio instructions, to ensure keeping the bubble in the correct position in the anterior chamber of the eye.

[0021] In the beginning of the operation, the glasses mount will be put on the patient’s head and it will stay there during the entire use of this tool. The purpose of using this glasses mount is to avoid undesired movements of the tool and to ease the assembly of the tool in case it was removed by the patient (e.g., while eating or using the bathroom). At the end of the operation, while the patient still lay on the operation bed, a calibration of the tool will take place, such that the patient will be instructed to look (with his unoperated eye) at a dedicated reference point presented on the display screen (the reference point is the point the patient needs to look at with his unoperated eye to ensure that the bubble is in the correct location in the operated eye). Examples of reference points include light (green light to reflect the correct location, red light to reflect incorrect location) or any other visual effect that will help the patient to keep the direction of gaze. A dedicated camera will record the operated eye to ensure that the bubble is indeed in the correct location.

[0022] Eye movements are measured using the eye tracker. Light, typically infrared, is reflected from the eye and sensed by a video camera or some other specially designed optical sensor. The information is then analyzed to extract eye rotation from changes in reflections.

[0023] A synchronization between the bubble location and the reference point is made to ensure that the patient’s gaze is ideal to locate the bubble in the anterior chamber in proximity to the graft. If the patient properly looks at the reference point, the display screen will mark success, and if the look deviates from the reference point, the patient will get an alert in the display screen (by changing the color of the reference point or any other visual effect). In parallel, the patient is provided with graphic instructions (e.g., arrows) via the screen and audio instructions in the headphones to help redirecting the gaze at the right location. The audio system allows the patient to hear music / podcasts / radio at her choice, to alleviate boredom and encourage collaboration, but in the event the patient looks away, audio instructions are provided instead so that the patient will comply with the instructions for directing the gaze or the need to change neck or head position.

[0024] Neck movements are monitored via the gyroscope and accelerometer-based sensors. Correction instructions are provided both via the display screen and via the headphones. Certain movements of the neck might be corrected via an instruction to change gaze direction (so that the bubble location is still ideal), but in case of more aggressive neck movements, the patient can be instructed to straighten the neck.

[0025] To monitor supine position, sensors are located on the shoulders (at the point of contact with the bed) and sense any detachment of the shoulders from the bed the patient is lying on. The instructions for the shoulders state are provided via screen and headphones.

[0026] The system is further capable of recording a plurality of parameters, including direction, size and speed of eye movements; number of deviations from the reference point; amount of time in which the bubble was not in the desired location; a colorful map that reflects the relative time of support by the bubble in different areas of the graft; neck or head movements (direction, size and speed); and amount of time that the patient did not keep the supine position.

[0027] Therefore, an aspect of the present disclosure provides a system for monitoring a post-ophthalmological procedure condition state in an eye of a subject (e.g. the location of a gas bubble supporting a cornea graft). The condition state is affected by bodily behavior of the subject, namely by movements of some body parts of the subject. The system includes an eye imaging system that comprises an imaging unit fixable or configured to be fixed with respect to the subject in a manner configured for imaging a plurality of images of the eye of the subject.

[0028] As used herein, the term "fixable with respect to the subject" refers to the capability of establishing and maintaining a stable spatial relationship between the imaging unit and the subject's body or a specific body part during the monitoring period. This encompasses any mechanical, structural, or coupling arrangement that prevents unwanted relative movement between the component and the subject, thereby ensuring consistent positioning and functionality. The fixation may be achieved through direct attachment to the subject (such as mounting on the head, neck, or other body parts), indirect attachment through intermediate structures (such as bed-mounted arms or stands positioned relative to the subject), or hybrid approaches combining multiple fixation methods. The fixation arrangement may be rigid, providing no relative movement, or may allow controlled movement within predetermined limits while maintaining the desired spatial relationship. The requirement for the fixation is that the spatial relationship between the component and the relevant anatomy remains sufficiently stable to enable accurate and consistent monitoring of the condition state throughout the intended monitoring period. Examples of fixable arrangements include, but are not limited to, head-mounted devices, wearable assemblies, bedside positioning systems, and adjustable mounting frameworks that can be secured in position relative to the subject.

[0029] The imaging unit may include a camera that can capture images in one or more spectral ranges. The imaging unit may also comprise an illumination unit for illuminating the eye with a specific light, e.g. infra-red light or visible range light to allow capturing images with desired properties. The system further comprises at least one processing circuitry configured for analyzing said plurality of images to identify said condition state and to determine if the condition state deviates from a predetermined allowed state. In other words, the processing circuitry is configured to determine the condition state and its relation to a predetermined allowed state. The allowed state is determined based on the ophthalmological procedure, such as Endothelial Keratoplasty, and it is determined after an initial setup of the system. Once the system is set, the allowed state is determined, e.g. by a manual or at least semi-automatic procedure by the physician. Therefore, as used herein, the term "allowed state" refers to a predetermined acceptable condition or parameter range for a monitored element within the eye following an ophthalmological procedure. In the context of post-endothelial keratoplasty care, the allowed state specifically defines the spatial boundaries within which a therapeutic gas bubble must remain to maintain effective support of a corneal graft and the imaging system constantly monitors the eye to determine whether the bubble is within its boundaries. The allowed state is established based on clinical requirements for optimal therapeutic efficacy and is typically defined through calibration input from medical personnel who specify the acceptable position, area, or range of positions for the monitored condition. When the monitored condition state falls within the allowed state, the therapeutic objective is being met; conversely, when the condition state deviates from or falls outside the allowed state, corrective intervention through patient positioning guidance becomes necessary. The allowed state may be defined as a specific location, a bounded area, a range of acceptable positions, or any combination thereof, and serves as the reference standard against which real-time monitoring data is continuously compared to determine the need for corrective instructions to the patient.

[0030] The processing circuitry is configured for identifying or determining if the condition state deviates from said predetermined allowed state, and upon identification or determination thereof, the processing circuitry is further configured for generating instructions data that comprises bodily behavior instructions for the subject for bringing the condition state into the predetermined allowed state. The bodily behavior instructions comprise instructions for changing bodily parameters of the subject, such as gaze direction, shoulders posture, neck or head orientation, etc. The system further includes an output unit that comprises one or more output elements for outputting said instructions data.

[0031] It is to be noted that any combination of the described embodiments with respect to any aspect of this present disclosure is applicable. In other words, any aspect of the present disclosure can be defined by any combination of the described embodiments.

[0032] In some embodiments of the system, the imaging system comprises an eye tracker for monitoring a gaze direction of said eye and generating gaze data indicative of the gaze direction of said eye. The gaze data is to be understood as a digital representation of the images captured by the eye tracker. The gaze data may by raw data of images or processed data that carries information of gaze direction detected by the eye tracker. It is to be noted that the eye tracker may track the fellow eye and by that assume that the eye of interest gazes in the same direction. The processing circuitry is configured for utilizing said gaze data for generating said instructions data. Namely, the bodily behavior instructions are taking into account the current gaze direction of the subject. In other words, the processing circuitry is configured to process the gaze data to determine whether the gaze direction is within allowed boundaries that were determined for the subject and by identifying deviation from these boundaries, the processing circuitry is configured to include respective instructions indicating the subject of the deviation from the boundaries with instructions how to correct it, e.g. by gazing to a different direction. It is to be noted that the instructions may also include positive feedback indicating that the gaze of the subject is within the allowed boundaries. This may result in instructions that include guidance for changing the gaze to a selected gaze direction that will result in bringing the condition state into the predetermined allowed state.

[0033] In some embodiments of the system, the imaging system comprises said eye tracker. Namely, the imaging system is serving two purposes - monitoring the condition state and monitoring the gaze direction.

[0034] In some embodiments, the system further comprises a head or neck orientation sensor configured for monitoring an orientation of a head or neck of the subject and generating head orientation data indicative of the head orientation of the subj ect. The head orientation data is a digital representation of the measurement of the orientation or orientation change of the head of the subject with respect to an initial position. This head orientation data may indicate what is the effect of the orientation of the head of the subject on the desired allowed state. The processing circuitry is configured for utilizing said head orientation data for generating said instructions data. Namely, the bodily behavior instructions are taking into account the head or neck orientation of the subject. Therefore, the processing circuitry is configured to process the images of the eye or the gaze data and the orientation data to determine the combined effect of the current orientation of the head and the gaze direction on the condition state. This may result in instructions that include guidance for changing the head or neck orientation to a selected head or neck orientation that will result in bringing the condition state into the predetermined allowed state.

[0035] In some embodiments of the system, the head orientation sensor comprises at least one of a gyroscope, an accelerometer or both gyroscope and accelerometer.

[0036] In some embodiments of the system, the head orientation sensor is mounted or mountable on the head or neck of the subject.

[0037] In some embodiments of the system, the head orientation sensor comprises a head orientation sensor mounting arrangement for mounting it on the head or neck of the subject.

[0038] As used herein, the "head orientation sensor mounting arrangement" for the head or neck orientation sensor encompasses various mechanical coupling systems configured to securely attach the sensor to the subject's head or neck region while maintaining sensor functionality and patient comfort. Such mounting arrangements may include, but are not limited to, adjustable headbands, elastic straps, adhesive patches, clip-on mechanisms, integrated headgear, or wearable accessories such as caps or collars. The mounting arrangement may be rigid, semi-rigid, or flexible, and may incorporate padding, cushioning, or other comfort-enhancing elements. The arrangement is designed to maintain consistent sensor positioning relative to the monitored body part while accommodating normal patient movement and ensuring reliable data transmission to the processing circuitry through wired or wireless communication links.

[0039] In some embodiments of the system, the head orientation sensor is mounted or mountable on a head of the subject.

[0040] In some embodiments of the system, the head orientation sensor is integral with the imaging system.

[0041] In some embodiments, the system further comprises shoulders orientation sensor configured for monitoring an orientation of shoulders of the subject and generating shoulders orientation data indicative of the shoulders orientation of the subject. The shoulders orientation data is a digital representation of the measurement of the orientation or orientation change of the shoulders of the subject with respect to an initial position, e.g. lying position. This shoulders orientation data may indicate what is the effect of the orientation of the shoulders of the subject on the desired allowed state. The processing circuitry is configured for utilizing said shoulders orientation data for generating said instructions data. Namely, the bodily behavior instructions are taking into account the shoulders orientation of the subject. Therefore, the processing circuitry is configured to process the images of the eye or the gaze data and the shoulders orientation data to determine the combined effect of the current orientation of the shoulders and the gaze direction on the condition state. In some embodiments, the combined effect is determined by the processing circuitry also based on the head orientation data. This may result in instructions that include guidance for changing the shoulders orientation to a selected shoulders orientation that will result in bringing the condition state into the predetermined allowed state.

[0042] In some embodiments of the system, the shoulders orientation sensor comprises one or more touch sensors attached to the shoulders of the subject and configured for detecting a contact between the shoulders of the subject and a lying surface on which the subject is intended to lie on, thereby indicating the shoulders orientation of the subject. In other words, the contact measurement profile between the shoulders and the lying surface is indicative of the orientation of the shoulders with respect to a certain initial position, which is typically a lying position. The one or more touch sensors are configured for transmitting the shoulders orientation data to the at least one processing circuitry either through wired communication or wireless communication.

[0043] In some embodiments of the system, the imaging system is mounted on a head of the subject.

[0044] In some embodiments of the system, the imaging system comprises an imaging system mounting arrangement for mounting it on the head the subject.

[0045] The "imaging system mounting arrangement" refers to structural support systems configured to position and maintain the eye imaging system in proper alignment with the subject's eye during monitoring. Such arrangements may comprise eyeglass frames, headset configurations, helmet-like structures, adjustable mounting arms, head-mounted displays, or goggle-type assemblies. The mounting arrangement may be designed to support single or multiple imaging components, including cameras, illumination sources, eye trackers, and display screens, while ensuring optical alignment and patient comfort. The arrangement may incorporate adjustment mechanisms for interpupillary distance, focal length, or angular positioning, and may be configured to accommodate prescription eyewear or integrate with other medical monitoring equipment mounted on the subject's head.

[0046] In some embodiments of the system, said one or more output elements comprise an audible output device, such as headphones.

[0047] In some embodiments of the system, said one or more output elements comprise a visual output device, such as a display presenting the instructions, a visual indicator indicating a location to which the gaze should be pointed towards.

[0048] In some embodiments of the system, said post-ophthalmological procedure is an Endothelial Keratoplasty and the condition state is a gas bubble location within the eye.

[0049] In some embodiments of the system, said predetermined allowed state is a selected predetermined area in the eye in which the gas bubble is allowed to be. In other words, the predetermined allowed state defines the area in the eye that the gas bubble should be in order to support its function to maintain the corneal graft in position. When the gas bubble exits that selected predetermined and confined area, it is regarded as no longer sufficiently supporting the corneal graft. The area in the eye is defined by certain boundaries that are detectable by the imaging system. The processing circuitry is configured to maintain monitoring of these boundaries defining the area with the data it receives from the imaging system. In some embodiments of the system, the at least one processing circuitry is configured to receive predetermined allowed state data indicative of the predetermined allowed state for determining said predetermined area. This may be an input of a physician after the procedure that indicates at least one processing circuitry that the current position of the bubble is good and the at least one processing circuitry may determine a tolerance around the current position to determine the selected predetermined and confined area. In other words, the processing circuitry is configured to receive an input, typically by a physician or other professional staff, that defines the area in which the gas bubble should be maintained. This input calibrates the system such that the monitoring and the guiding instructions are made in order to ensure that the gas bubble maintains in the desired area.

[0050] In some embodiments of the subject, the bodily behavior instructions comprise instructions to change or maintain body part position or orientation.

[0051] In some embodiments of the subject, the bodily behavior instructions comprise instructions to change any one of: gaze direction, head orientation, shoulder orientation, or any combination thereof.

[0052] In some embodiments of the system, the output unit comprises at least one of: audio output interface, such as a speaker, a display, visual indicators, such as LEDs, or any combination thereof.

[0053] Yet another aspect of the present disclosure provides a method for monitoring a post-ophthalmological procedure condition state in an eye of a subject. The condition state is affected by bodily behavior of the subject. The method comprising: imaging a plurality of images of the eye of the subject; analyzing said plurality of images to identify said condition state to determine if the condition state deviates from a predetermined allowed state; responsive to determination of said deviation from said predetermined allowed state, the method further generating instructions data that comprises bodily behavior instructions for the subject for bringing the condition state into the predetermined allowed state; and outputting said instructions data to the subject that will result a desired bodily behavior change to bring the condition state to the predetermined allowed state.

[0054] In some embodiments, the method further comprises monitoring a gaze direction of said eye and generating gaze data indicative of the gaze direction of said eye. Said generating comprises utilizing said gaze data for generating said instructions data. In some embodiments, the method further comprises monitoring an orientation of a head of the subject and generating head orientation data indicative of the head orientation of the subject. Said generating comprises utilizing said head orientation data for generating said instructions data.

[0055] In some embodiments, the method further comprises monitoring an orientation of shoulders of the subject and generating shoulders orientation data indicative of the shoulders orientation of the subject. Said generating comprises utilizing said shoulders orientation data for generating said instructions data.

[0056] In some embodiments of the method, said monitoring an orientation of shoulders of the subject comprises detecting a contact between the shoulders of the subject and a lying surface on which the subject is intended to lie on or lies on, thereby indicating the shoulders orientation of the subject.

[0057] In some embodiments of the method, said outputting comprises outputting said instructions data audibly.

[0058] In some embodiments of the method, said outputting comprises outputting said instructions data visually.

[0059] In some embodiments of the method, said post-ophthalmological procedure is an Endothelial Keratoplasty and the condition state is a gas bubble location within the eye.

[0060] In some embodiments, the method further comprises said predetermined allowed state is a selected predetermined area in the eye in which the gas bubble is allowed to be.

[0061] In some embodiments, the method further comprises receiving said predetermined allowed state data indicative of the predetermined allowed state for determining said predetermined area.

[0062] In some embodiments, the method is carried out by the system of any one of the above-described embodiments or any combination thereof.

[0063] Yet another aspect of the present disclosure provides a gaze direction guiding system for use in ophthalmological procedure. The system comprises a head fixation unit configured for fixing the head of the subject in a fixation or fixed position. The fixation or fixed position is the selected desired position for the head of the subject that is suitable for performing the ophthalmological procedure. The fixed position may include orientation of the head with respect to other body part, such as the torso. The system further comprises a gaze direction guiding unit configured for outputting gaze direction instructions to the subject. The gaze direction instructions indicate the gaze direction the subject is required to gaze to with an eye not undergoing the ophthalmological procedure. Namely, the unoperated eye. The conjugation of the eyes will cause the operated eye to gaze in the desired direction. The system further comprises an input unit configured for receiving input data indicative of a required gaze direction of the subject. At least one processing circuitry of the system is configured for receiving and analyzing said input data indicative of a required gaze direction of the subject and operating the gaze direction guiding unit to output said gaze direction instructions based on the input data. Namely, the input data indicates the required gaze directions, and the processing circuitry operates the gaze direction guiding unit to output gaze direction instructions that instruct the subject to gaze towards the required gaze direction.

[0064] In some embodiments of the system, said gaze direction instructions comprise visual instructions.

[0065] In some embodiments of the system, the visual instructions comprise displaying a visual indicator indicating the required gaze direction. This can be a certain light source that is turned on and indicates the required gaze direction or a certain symbol presented on a screen.

[0066] In some embodiments of the system, the gaze direction guiding unit comprises a display for displaying the visual instructions.

[0067] In some embodiments of the system, said gaze direction instructions comprise audible instructions, namely audible output, e.g. through headphones or speakers that explain the subject where to gaze according to the required gazed direction.

[0068] In some embodiments of the system, the gaze direction guiding unit comprises a speaker of headphones for outputting the audible instructions.

[0069] In some embodiments of the system, the gaze direction guiding unit is configured for undergoing a calibration process for determining a reference eye position. The at least one processing circuitry is configured for utilizing said reference eye position for said operating. In other words, the processing circuitry uses the reference eye position, that indicates the position of the eye with respect to the gaze direction guiding unit, when operating the gaze direction guiding unit to output the gaze direction instructions.

[0070] In some embodiments of the system, the input unit is configured for receiving said input data by a vocal input, namely a vocal indication by the physician performing the surgery that indicates the required gaze direction. The physician may instruct the system to output gaze direction instructions for any desired direction. In some embodiments of the system, the input unit is configured for receiving said input data by touch-based input.

[0071] In some embodiments of the system, the gaze direction guiding unit is fixedly couplable to the head fixation unit.

[0072] BRIEF DESCRIPTION OF THE DRAWINGS

[0073] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0074] Fig- 1 is a block diagram of a non-limiting example of an embodiment of a system for monitoring a post-ophthalmological procedure condition state in an eye of a subject according to an aspect of the present disclosure.

[0075] Fig- 2 is a block diagram of a non-limiting example of an embodiment of a gaze direction guiding system for use in ophthalmological procedure according to an aspect of the present disclosure.

[0076] Fig- 3 is a schematic illustration of a non-limiting example of the imaging system and output elements embedded in glasses.

[0077] DETAILED DESCRIPTION

[0078] The following figures are provided to exemplify embodiments and realization of the invention of the present disclosure.

[0079] Reference is now made to Fig. 1, which is a block diagram of exemplary embodiment of the system of the present disclosure. Fig 1 exemplifies a system 100 for monitoring a post-ophthalmological procedure condition state in an eye of a subject. For example, the post-ophthalmological procedure is an Endothelial Keratoplasty and the condition state is a gas bubble location within the eye, supporting a cornea graft. To avoid incomplete corneal graft problems, and to lower the risk of graft detachment, the gas bubble is inserted to stabilize the graft. However, the gas bubble can only be effective if it covers the graft. The location of the gas bubble is affected by bodily behavior, i.e., movement of the subject. Meaning, if the subject changes their gaze direction, or moving their neck or head, or moving their shoulders, it immediately affects the location of the gas bubble. The gas bubble has a predetermined allowed state, meaning, it has a specific, confined area in the eye in which it is allowed to be in order for the results of the procedure to be successful. Since the location of the gas bubble is affected by the movement of the subject, it is important for the subject to remain still in a specific position so the bubble will remain in the desired, predetermined area. The disclosed system 100 performs constant monitoring of the location of the gas bubble, and once a change in the location of the bubble is detected, the system 100 outputs a set of appropriate instructions of specific body movements the subject needs to perform which will result in the gas bubble returning to its predetermined area in the subject's eye. The system 100 may also output feedback to the subject whether the instructions are performed correctly. This may include (1) feedback that indicates whether the body movements performed by the subject are getting the gas bubble towards the predetermined confined area and (2) whether the gas bubble entered the predetermined confined area.

[0080] Specifically, the system 100 comprises an eye imaging system 102 that includes an imaging unit 103, which generates image data ImD that comprises multiple images of the eye, taken using a camera. The imaging system 102 serves two purposes. The first is to monitor the condition state, i.e., the location of the gas bubble, through the multiple images taken by the imaging unit 103 and to generate image data ImD, representing the collected multiple images. The process of monitoring the location of the gas bubble allows the system to determine if it has deviated from the predetermined allowed state. The second purpose of the image system is to monitor the gaze direction of the subject, using an eye tracker 105, and to generate gaze data GD indicative of the gaze direction of the subject. The eye imaging system 102 may be mounted on the subject’s head by, for example, a pair of glasses or any headset mount that is capable of being mounted on the subject’s head. The imaging unit 103 and the eye tracker 105 can be, in some embodiments, two separate elements, and in other embodiments they can be the same element that is used for the two purposes.

[0081] The system 100 also comprises a head orientation sensor 104 configured for monitoring the orientation of the head and or neck of the subject and to generate head orientation data HOD indicative of the head orientation of the subject. The head orientation sensor may comprise a gyroscope, and / or an accelerator, and may be mounted on the head or neck of the subject. It also may be integral with the imaging system 102, e.g. be part of the glasses carrying the imaging system.

[0082] Yet another sensor the system 100 comprises is shoulder orientation sensor 106 which may comprise touch sensors, configured to monitor the orientation of the shoulders of the subject and to generate shoulders orientation data SOD which indicates the orientation of the shoulders of the subject. The touch sensors are attached to the shoulders of the subject, for detecting a contact between the shoulders of the subject and a lying surface, such as a procedural bed on which the subject is lying on during the medical procedure.

[0083] The system 100 also comprises a processing circuitry 108 that is configured to receive predetermined allowed state data PASD indicative of the predetermined allowed state for determining the confined area in which the gas bubble should be located in the eye of the subject. This can be regarded as a calibration step in which the system receives an input by a physician or other caregiver that indicates the area that the gas bubble should be maintained in. For example, it can be a marking on an image of the eye of the subject that the gas bubble was injected into. The marking marks the area of the bubble, and optionally also some allowed margins around the bubble. After receiving the input, the processing circuitry 108 is operating in order to monitor the location of the gas bubble with respect to the marked area and to output an output to the subject guiding him / her to move one or more body parts in order to maintain or bring the gas bubble to the predetermined allowed state, namely into the allowed area. Therefore, the processing circuitry 108 is further configured to receive the image data Img to determine if the condition state deviates from the predetermined allowed state, i.e., if the current location of the gas bubble is not aligned with the determined confined area in the subject's eye in which the bubble should be located in. If so, there is a need to generate instructions for the subject to perform several bodily movements, such that the condition state will return to the predetermined allowed state, meaning, to move the gas bubble so it will occupy its predetermined confined area. The processing circuitry 108 receives data from multiple sources (sensors), comprising (1) the gaze data GD from the imaging unit 103, indicating the direction of the gaze of the subject; (2) the head orientation data HOD indicating the orientation of the head or neck of the subject; and (3) the shoulders orientation data SOD, indicating the orientation of the shoulders of the subject. Using this data, the processing circuitry 108 generates instruction data ID, which provides the subjects with instructions of which bodily movements they need to perform. For example, the instructions may include changing the direction of the gaze, moving the head to a certain direction, and changing their lying position. It is to be noted that in order to bring the gas bubble to the predetermined area in the eye, it may be required to perform a combination of types of body movements, i.e., shoulders movement, gaze movement and head movement.

[0084] An example of an imaging system and output elements of an output unit can be seen in Fig- 3, which is schematic illustration of a non-limiting example of the imaging system and output elements embedded in glasses. The imaging system 370 and the output elements 372 are mounted on glasses 374. When the glasses are worn by the subject, the spatial relationship between the imaging system 370 and the eye of the subject remains fixed, allowing to monitor the eye and the condition state. The output elements 372 are LEDs that may indicate the subject how to fix his / her gaze direction or whether the gaze direction is satisfying. For example, the indication may be with different light colors emitted from the LEDs and can be also accompanied by audible feedback from an audible output element (not shown).

[0085] The system 100 also comprises an output unit 110, which receives the instruction data ID and delivers the instructions to the subject, accordingly. The output unit 110 comprises one or more output elements for supporting the appropriate output format of the instructions. Thus, the one or more output elements may comprise an audible device, such as headphones / speakers, for allowing an audible instructions output. Furthermore, the output elements may comprise a screen which is located in front of the subject's eyes, for allowing the instructions to be outputted in a visual format (e.g., textual instructions or light-based instructions). This screen may be located, for example, on a pair of glasses that the subject is wearing. These glasses may be the same glasses which contain the imaging system 102. In the case of instructing the subject to change their gaze direction in a visual output format, the instructions may be in the form of presenting an object on the screen to which the subject is instructed to look towards.

[0086] Reference is now made to Fig. 2, which is a block diagram of an embodiments of a non-limiting example of a gaze direction guiding system for use in ophthalmological procedure.

[0087] Eye movement during eye surgery is highly problematic because it can damage delicate structures, compromise surgical precision, and increase the risk of complications. For example, Cataract surgery is mainly performed under local anesthesia, which lacks akinesia (lack of muscle movement). To minimize eye movement, surgeons instruct patients to look directly at the microscope light and remain still. However, this instruction is often not sufficiently clear for patients. During certain stages of the surgery (e.g., phacoemulsification), the patient's inability to see the microscope light can lead to involuntary eye movement. If the patient fails to cooperate, surgeons may need to use forceps to stabilize the eye, but this limits their ability to use both hands simultaneously - often essential during the procedure.

[0088] The system exemplified in Fig. 2, provides a solution to overcome the above issues. The system 250 comprises a head fixation unit 252 for fixing the head of the subj ect undergoing the procedure in position during the procedure. After the head is fixed, a gaze direction guiding unit 254 is positioned in front of the subject such that at least the unoperated eye of the subject can see the gaze direction guiding unit 254. The gaze direction guiding unit may be integral with the head fixation unit 252 or an independent component. The gaze direction guiding unit is configured for outputting an output, in the form of gaze direction instruction, indicating the subject to gaze towards a required gaze direction. After the gaze direction guiding unit 254 is positioned, a calibration process typically takes place, in which a reference position of the eye is determined and the gaze direction instruction that will follow will be based on the reference position. An input unit 260 of the system is configured to receive input data indicative of the required gaze direction at the specific time of the procedure. The system further comprises a processing circuitry 258 that is configured for analyzing said input data to thereby operate the gaze direction guiding unit 254 to output the gaze direction instructions so that the subject will gaze towards the required gaze direction. The output of the gaze direction instructions may be audible, visual or a combination of audible and visual outputs. For example, the gaze direction guiding unit 254 may output the instructions by illuminating a specific light, displaying a certain sign on a display, audibly instructing via headphones or speakers, or any other suitable format of output of the instruction that will be clear for the subject so he / she can comply.

Claims

CLAIMS:

1. A system for monitoring a post-ophthalmological procedure condition state in an eye of a subject, said condition state is affected by bodily behavior of the subject, the system comprising: an eye imaging system that comprises an imaging unit configured to be fixed with respect to the subject for imaging a plurality of images of the eye of the subject; at least one processing circuitry configured for analyzing said plurality of images to identify said condition state and to determine if the condition state deviates from a predetermined allowed state; wherein the at least one processing circuitry is configured to, responsive to the determination of the condition state deviates from said predetermined allowed state, generating instructions data that comprises bodily behavior instructions for the subject for bringing the condition state into the predetermined allowed state; an output unit that comprises one or more output elements for outputting said instructions data to the subject.

2. The system of claim 1, wherein the imaging system comprises an eye tracker for monitoring a gaze direction of said eye and generating gaze data indicative of the gaze direction of said eye; wherein the processing circuitry is configured for utilizing said gaze data for generating said instructions data.

3. The system of claim 2, wherein the imaging system comprises said eye tracker.

4. The system of any one of claims 1-3, comprising a head orientation sensor configured for monitoring an orientation of a head of the subject and generating head orientation data indicative of the head orientation of the subject; wherein the processing circuitry is configured for utilizing said head orientation data for generating said instructions data.

5. The system of claim 4, wherein the head orientation sensor comprises at least one of a gyroscope, an accelerometer or both gyroscope and accelerometer.

6. The system of claim 4 or 5, wherein the head orientation sensor is mountable on the head or neck of the subject.

7. The system of any one of claims 4-6, wherein the head orientation sensor is mountable on a head of the subject.

8. The system of any one of claims 4-7, wherein the head orientation sensor is integral with the imaging system.

9. The system of any one of claims 1-8, comprising shoulders orientation sensor configured for monitoring an orientation of shoulders of the subject and generating shoulders orientation data indicative of the shoulders orientation of the subject; wherein the processing circuitry is configured for utilizing said shoulders orientation data for generating said instructions data.

10. The system of claim 9, wherein the shoulders orientation sensor comprises one or more touch sensors attached to the shoulders of the subject and configured for detecting a contact between the shoulders of the subject and a lying surface on which the subject is intended to lie on, thereby indicating the shoulders orientation of the subject.

11. The system of any one of claims 1-10, wherein the imaging system is mountable on a head of the subject.

12. The system of any one of claims 1-11, wherein said one or more output elements comprise an audible output device.

13. The system of any one of claims 1-12, wherein said one or more output elements comprise a visual output device.

14. The system of any one of claims 1-13, wherein said post-ophthalmological procedure is an Endothelial Keratoplasty and the condition state is a gas bubble location within the eye.

15. The system of claim 14, wherein said predetermined allowed state is a selected predetermined area in the eye in which the gas bubble is allowed to be.

16. The system of claim 14, wherein the at least one processing circuitry is configured to receive predetermined allowed state data indicative of the predetermined allowed state for determining said predetermined area.

17. A gaze direction guiding system for use in ophthalmological procedure, the system comprising: a head fixation unit configured for fixing the head of the subject in a fixed position; a gaze direction guiding unit configured for outputting gaze direction instructions to the subject, the gaze direction instructions indicating the gaze direction the subject is required to gaze to with an eye not undergoing the ophthalmological procedure;an input unit configured for receiving input data indicative of a required gaze direction of the subject; at least one processing circuitry configured for receiving and analyzing said input data and operating the gaze direction guiding unit to output said gaze direction instructions based on the input data.

18. The gaze direction guiding system of claim 17, wherein said gaze direction instructions comprise visual instructions.

19. The gaze direction guiding system of claim 18, wherein the visual instructions comprise displaying a visual indicator indicating the required gaze direction.

20. The gaze direction guiding system of claim 18 or 19, wherein the gaze direction guiding unit comprises a display for displaying the visual instructions.

21. The gaze direction guiding system of any one of claim 17-20, wherein said gaze direction instructions comprise audible instructions.

22. The gaze direction guiding system of claim 21 , wherein the gaze direction guiding unit comprises a speaker of headphones for outputting the audible instructions.

23. The gaze direction guiding system of any one of claims 17-22, wherein the gaze direction guiding unit is configured for undergoing a calibration process for determining a reference eye position, wherein said at least one processing circuitry is configured for utilizing said reference eye position for said operating.

24. The gaze direction guiding system of any one of claims 17-23, wherein the input unit is configured for receiving said input data by a vocal input.

25. The gaze direction guiding system of any one of claim 17-24, wherein the input unit is configured for receiving said input data by touch-based input.

26. The gaze direction guiding system of any one of claims 17-25, wherein the gaze direction guiding unit is fixedly couplable to the head fixation unit.

27. A method for monitoring a post-ophthalmological procedure condition state in an eye of a subject, said condition state is affected by bodily behavior of the subject, the method comprising: imaging a plurality of images of the eye of the subject; analyzing said plurality of images to identify said condition state to determine if the condition state deviates from a predetermined allowed state; responsive to determination of said deviation from said predetermined allowed state, the method further generating instructions data that comprises bodily behaviorinstructions for the subject for bringing the condition state into the predetermined allowed state; outputting said instructions data to the subject.

28. The method of claim 27, further comprising monitoring a gaze direction of said eye and generating gaze data indicative of the gaze direction of said eye; wherein said generating comprises utilizing said gaze data for generating said instructions data.

29. The method of claim 27 or 28, further comprising monitoring an orientation of a head of the subject and generating head orientation data indicative of the head orientation of the subject; wherein said generating comprises utilizing said head orientation data for generating said instructions data.

30. The method of any one of claims 27-29, further comprising monitoring an orientation of shoulders of the subject and generating shoulders orientation data indicative of the shoulders orientation of the subject; wherein said generating comprises utilizing said shoulders orientation data for generating said instructions data.

31. The method of claim 30, wherein said monitoring an orientation of shoulders of the subject comprises detecting a contact between the shoulders of the subject and a lying surface on which the subject is intended to lie on or lies on, thereby indicating the shoulders orientation of the subject.

32. The method of any one of claims 27-31, wherein said outputting comprises outputting said instructions data audibly.

33. The method of any one of claims 27-32, wherein said outputting comprises outputting said instructions data visually.

34. The method of any one of claims 27-33, wherein said post-ophthalmological procedure is an Endothelial Keratoplasty and the condition state is a gas bubble location within the eye.

35. The method of claim 34, wherein said predetermined allowed state is a selected predetermined area in the eye in which the gas bubble is allowed to be.

36. The method of claim 35, comprising receiving predetermined allowed state data indicative of the predetermined allowed state for determining said predetermined area.

37. The method of any one of claims 27-36 carried out by the system of any one of claims 1-16.

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