ELECTRONIC Ophthalmic Lens With Medical Monitoring

专利摘要:
An ophthalmic lens having an electronic system is described in the present disclosure for monitoring the user's medical condition using at least one sensor and at least one problem model. in an additional embodiment, the problem model includes a pattern and / or a threshold. In at least one embodiment, the lens operates in conjunction with a second lens and / or an external device to monitor a medical condition or to perform a user test protocol. Examples of at least one sensor include an eyelid position sensor system, an eye movement sensor system, a biosensor, a bioimpedance sensor, a temperature sensor, and a pulse oximeter.
公开号:BR102017012241A2
申请号:R102017012241-7
申请日:2017-06-08
公开日:2018-01-02
发明作者:B. Pugh Randall；Toner Adam
申请人:Johnson & Johnson Vision Care, Inc.；
IPC主号:

专利说明:

(54) Title: ELECTRONIC OPHTHALMIC LENS
WITH MEDICAL MONITORING (51) Int. Cl .: G06F 17/30; G02C 7/04; A61F 2/16 (30) Unionist Priority: 10/06/2016 US 15 / 179,184 (73) Holder (s): JOHNSON & JOHNSON VISION CARE, INC.
(72) Inventor (s): RANDALL B. PUGH; ADAM TONER (74) Attorney (s): DANNEMANN, SIEMSEN, BIGLER & IPANEMA MOREIRA (57) Abstract: An ophthalmic lens having an electronic system is described in the present disclosure for monitoring the user's medical condition using at least one sensor and least a problem model. In an additional embodiment, the problem model includes a pattern and / or a threshold. In at least one embodiment, the lens operates in conjunction with a second lens and / or an external device to monitor a medical condition or to execute a user test protocol. Examples of at least one sensor include an eyelid position sensor system, an eye movement sensor system, a biosensor, a bioimpedance sensor, a temperature sensor and a pulse oximeter.
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Descriptive Report of the Invention Patent for ELECTRONIC OPHTHALMIC LENS WITH MEDICAL MONITORING. BACKGROUND OF THE INVENTION
1. Field of the invention [0001] The present invention relates to an energized or electronic ophthalmic lens and, more particularly, an energized or electronic ophthalmic lens that has a sensor, as well as associated hardware and software for monitoring one or more medical conditions (or states) of the lens wearer.
2. Discussion of the related technique [0002] As continuous electronic devices to be miniaturized, there is an increasing probability of creating microelectronic devices that can be used close to the user's body, in a variety of applications. Such uses may include monitoring aspects of body chemistry, administering controlled dosages of drugs or therapeutic agents through various mechanisms, including automatically, in response to measurements, or in response to external control signals, and increased organ performance or fabrics. Examples of such devices include glucose infusion pumps, pacemakers, defibrillators, ventricular assist devices and neurostimulators. A new particularly useful field of application is that of contact lenses and ophthalmic lenses with technology to be worn on the body. For example, a lens with technology to be worn close to the body can incorporate a set of lenses with an electronically adjustable focus to increase or improve the performance of the eye. In another example, with or without an adjustable focus, a contact lens with technology to be used close to the body may incorporate electronic sensors to detect concentrations of specific chemicals in the pre-corneal (tear) film. The use of electronics integrated into a competition 870170039233, of 06/08/2017, p. 6/437
2/114 next to lenses introduces a potential requirement for communication with electronics, for a method of energizing and / or re-energizing electronic circuits, for interconnecting electronic circuits, for internal and external detection and / or monitoring, and for control electronics and the general function of the lens.
[0003] The human eye has the ability to discern millions of colors, adjust easily to changing light conditions and transmit signals or information to the brain at a rate that exceeds that of a high-speed Internet connection. Lenses, such as contact lenses and intraocular lenses, are currently used to correct vision defects, such as myopia (hypometropia), hyperopia (hyperopia), presbyopia and astigmatism. However, properly designed lenses incorporating additional components can be used to improve vision, as well as to correct vision defects.
[0004] Contact lenses can be used to correct myopia, hyperopia, astigmatism and other defects in visual acuity. Contact lenses can also be used to enhance the natural look of the wearer's eyes. Contact lenses, or lenses, are simply lenses placed on the anterior surface of the eye. Contact lenses are considered medical devices, and can be used to correct vision and / or for cosmetic or other therapeutic reasons. Contact lenses have been used commercially to improve vision since the 1950s. Old contact lenses were produced or manufactured from rigid materials, and were relatively expensive and fragile. In addition, these old contact lenses were made from materials that did not allow enough oxygen to be transmitted through the contact lens to the conjunctiva and cornea, which could potentially cause several adverse clinical effects. Although these contact lenses are still used, they are not suitable for all patients. Petition 870170039233, 06/06/2017, p. 7/437
3/114 due to its unsatisfactory initial comfort. Further developments in the field gave rise to flexible, hydrogel-based contact lenses, which are extremely popular and widely used today. Specifically, the silicone hydrogel contact lenses that are available today combine the benefit of silicone, which has extremely high oxygen permeability, with the proven comfort and clinical performance of hydrogels. Essentially, these hydrogel and silicone-based contact lenses are more permeable to oxygen and are, in general, more comfortable to wear than contact lenses made from previous rigid materials.
[0005] Conventional contact lenses are polymeric structures with specific shapes to correct various vision problems, as briefly presented above. In order to obtain the improved functionality, several circuits and components need to be integrated with these polymeric structures. For example, control circuits, microprocessors, communication devices, power supplies, sensors, actuators, light emitting diodes and miniature antennas can be integrated into contact lenses using customized optoelectronic components, not only to correct vision, but to improve vision and also provide additional functionality, as explained here. Electronic and / or energized ophthalmic lenses can be designed to provide enhanced vision through enlargement and reduction features, or simply by modifying the refractive capabilities of the lenses. Electronic and / or energized contact lenses can be designed to improve color and resolution, display text information, translate speech into subtitles in real time, offer visual cues from a navigation system, and provide image processing and internet access. The lenses can be designed to allow the wearer
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4/114 see in low light conditions. Electronic elements and / or sets of electronic elements on lenses, with appropriate design, can allow the projection of an image on the retina, for example, without an optical lens with variable focus, and provide innovative ways of displaying images. Alternatively, or in addition to any of these functions, or similar functions, contact lenses may incorporate components for non-invasive monitoring of biomarkers and health indicators of the user. For example, sensors integrated into the lens can allow a diabetic patient to monitor blood sugar levels by analyzing components of the tear film, without the need to draw blood. In addition, a properly configured lens can incorporate sensors to monitor cholesterol, sodium and potassium levels, as well as other biological markers. This, coupled with a wireless data transmitter, could allow a doctor to have almost immediate access to a patient's blood chemistry, without the patient having to waste time going to a laboratory and drawing blood. In addition, sensors integrated into the lens can be used to detect incident light in the eye to compensate for ambient light conditions, or for use in determining blink patterns.
[0006] The appropriate combination of devices could result in potentially unlimited functionality; however, there are several difficulties associated with incorporating extra components into an optical grade polymer part. For various reasons, it is generally difficult to manufacture such components directly on the lens, as well as installing and interconnecting flat devices on a non-planar surface. It is also difficult to manufacture on a scale. The components to be placed on or inside the lens need to be miniaturized and integrated with just 1.5 square centimeters of a transPetition polymer 870170039233, from 06/08/2017, p. 9/437
5/114 relative, while protecting the components against the liquid environment in the eye. It is also difficult to make a contact lens comfortable and safe for the user with the added thickness of the additional components.
[0007] Due to the area and volume restrictions of an ophthalmic device such as a contact lens, and the environment in which it is to be used, the physical embodiment of the device must overcome several problems, including the installation and interconnection of various electronic components on a non-planar surface, the volume of which comprises optical plastic. Consequently, there is a need to provide an electronic contact lens that is both mechanically and electrically robust.
[0008] As they are energized lenses, energy or, more particularly, current consumption to make electronic elements work, is a concern considering battery technology on the scale for an ophthalmic lens. In addition to normal current consumption, powered devices or systems of this nature generally require current reserves for standby, precise voltage control and switching capabilities to ensure operation over a potentially wide range of operating parameters, and consumption explosion, for example, up to eighteen (18) hours on a single charge, after potentially remaining inactive for years. Consequently, there is a need for a system that is optimized for reliable service, safety and size, at a low cost and in the long term, while providing the necessary power.
[0009] In addition, because of the complexity of the functionality associated with an energized lens and the high level of interaction between all the components that make up an energized lens, there is a need to coordinate and control the general operation of elePetição 870170039233, from 08 / 06/2017, p. 10/437
6/114 electronic and optical elements that constitute an energized ophthalmic lens. Consequently, there is a need for a system to control the operation of all other components, which is safe, low-cost and reliable, which has a low power consumption rate and which is scalable for incorporation into an ophthalmic lens.
[0010] Energized or electronic ophthalmic lenses may have to take into account certain unique physiological functions of the individual using the energized or electronic ophthalmic lens. More specifically, energized lenses may have to consider the blink, including the number of blinks in a given period of time, the duration of the blink, the time between blinks and any number of possible blink patterns, for example, if the individual is falling asleep. Blink detection can also be used to provide certain functionality, for example, blink can be used as a means to control one or more aspects of an energized ophthalmic lens. In addition, external factors, such as changes in light intensity levels and the amount of visible light that a person's eyelid blocks, need to be taken into account when determining blinks. For example, if a room has a lighting level between fifty-four (54) and one hundred and sixty-one (161) lux, a photosensor should be sensitive enough to detect changes in light intensity that occur when a person blinks.
[0011] Ambient light sensors, or photosensors, are used in many systems and products, for example, in televisions to adjust brightness according to ambient light, in luminaires to be turned on when dark, and in phones to adjust the screen brightness. However, these sensor systems currently in use are not small enough and / or do not have sufficiently low power consumption to incorporate contact lenses.
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7/114 [0012] It is also important to note that different types of blink detectors can be implemented with computer vision systems aimed at the user's eye (s), such as a camera digitally connected to a computer . The software running on the computer can recognize visual patterns as open and closed eye. These systems can be used in ophthalmic clinical settings, for diagnostic and study purposes. Unlike the detectors and systems described above, these systems are intended for use outside the eyes, and to face the eyes, rather than facing away from the eyes. Although these systems are not small enough to be incorporated into contact lenses, the software used may be similar to the software that would work in conjunction with powered contact lenses. Either system can incorporate software implementations of artificial neural networks that learn from inputs and adjust their output as needed. Alternatively, non-biobased software implementations that incorporate statistics, other adaptive algorithms and / or signal processing can be used to create intelligent systems.
[0013] There are several jobs that require the worker to be alert and awake, for example, a truck driver, a security guard and a military team on duty. It would be counterproductive and lead to possible problems if the worker fell asleep while performing his tasks. Many of these jobs are such that it is necessary for the worker to have mobility when carrying out his tasks and, therefore, a fixed-based monitoring system is not practical to provide the monitoring of these workers. In addition, there are many jobs that require regulated amounts of sleep in hours of rest, which are manually recorded by the worker instead of having the worker's automatic sleep record
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8/114 to provide better records.
[0014] Consequently, there is a need for a means and method for detecting certain physiological functions, such as the duration of an eye closure or a blink. The sensor used needs to be sized and configured for use on a contact lens. In addition, there is a need to detect the position of a user's eyelid. An eyelid position sensor could be used to detect that a user is falling asleep, for example, to record a user data event that is falling asleep. There are systems in place to detect the position of the eyelid; however, they are limited to devices such as camera image makers, image recognition and infrared detector / emitter pairs that depend on reflection from the eye and eyelid. The existing systems for detecting the position of the eyelid also depend on the use of glasses or clinical environments and are not easily contained within a contact lens.
SUMMARY OF THE INVENTION [0015] In at least one embodiment, an energized ophthalmic lens includes a contact lens; and an eyelid position sensor system, at least partially encapsulated in the contact lens, said eyelid position sensor system being configured to detect a vertical eyelid position, and a signal conditioner configured to individually sample each sensor in said system sensor to detect the position of the eyelid and provide an output signal from the position of the eyelid; an eye movement sensor system at least partially encapsulated in the contact lens, wherein the eye movement sensor system includes at least one movement sensor to track and determine the position of the eye, and a cooperatively associated signal conditioner to said motion sensor and configured to track and determine the position 870170039233, from 06/08/2017, p. 13/437
9/114 tion of the eye in spatial coordinates, based on the information from the output of said motion sensor, and provide an output motion signal; a system controller in electrical communication with said eyelid position sensor system and said eye movement sensor system, said system controller having an associated memory containing a plurality of problem models and at least two sets of recorders to store the data received from said eyelid position sensor system and said eye movement sensor system, said system controller being configured to compare the received eyelid position output data and motion signal data output with said plurality of problem models and generate a control signal when at least one problem model is satisfied, and at least one alert mechanism in electrical communication with said system controller, said alert mechanism being configured to receive the output control signal and capable of at least one of the actions of providing an alert and storing the data. In another additional embodiment, the at least one of the plurality of problem models is based on the historical data of an intended user of said lens.
[0016] In a mode additional to any of the above modes, the energized ophthalmic lens additionally includes a data entry by the user in electrical communication with said system controller; and a storage memory in electrical communication with said system controller, and said controller includes a buffer memory for storing a plurality of signals from said sensor position and said motion sensor eye lid system, so that upon receipt of a signal from said data entry by the user, the system controller copies the data in the buffer memory to said memory
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10/114 of storage. In another embodiment, data entry by the user includes a receiver capable of wirelessly receiving input from an individual to store the data present in said buffer memory.
[0017] In a mode additional to any of the above modes, the energized ophthalmic lens additionally includes a receiver in electrical communication with said system controller, said receiver being configured to receive a data request from an external device ; and a transmitter in electrical communication with said system controller and said storage memory, and said system controller in response to a received data request transmitting, through said transmitter, the contents of said storage memory to the external device. In a mode additional to any of the above modes, the system controller determines an oscillating signal from said eye movement sensor system, said system controller copies the data in the buffer memory to a storage memory. In an embodiment additional to any of the above embodiments, the eye movement sensor system includes at least one photodetector positioned to capture an image of the eye; at least one camera facing the iris configured to detect changes in images, patterns or contrast to track eye movement; at least one accelerometer to track the movement of at least one of the eye or contact lens; and at least one neuromuscular sensor configured to detect neuromuscular activity associated with eye movement. In an embodiment additional to any of the above embodiments, the eye motion sensor system further comprises a signal processor configured to receive signals from said motion sensor, perform digital signal processing and emit
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11/114 one or more signals to the system controller.
[0018] In a mode additional to any of the above modes, the system controller detects a change in the size of the pupil in response to a change in the condition of the ambient light detected by said eyelid position sensor, and the size of the pupil is based on at least one signal from said eye movement sensor, said system controller sending the control signal to said alert mechanism. In a mode additional to any of the above modes, the system controller detects a stable reading of the accelerometer in a direction indicating that a user is in a prone position after a rapid acceleration in that direction where the readings are coming from said sensor system. eye movement; said system controller sends the control signal to said alert mechanism. In a modality in addition to any of the above, the spatial coordinates are in three dimensions. In a modality in addition to any of the above, the motion sensor includes at least one accelerometer; and said system controller compares each signal from said at least one accelerometer with a threshold, wherein when any signal exceeds the threshold, said system controller sends a control signal to said alert mechanism. In an embodiment additional to any of the above embodiments, the energized ophthalmic lens additionally includes a light source facing the iris in electrical communication with said system controller; and at least one photosensor facing the iris willing to receive reflected light around the eye, in which said light originates from said light source, said at least one photosensor being in electrical communication with said controller of system; a transmitter in electrical communication with said system controller, and said said controller of
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12/114 The system is configured to send a signal from the oximeter to said light source and receive a signal from said at least one photosensor, the said signal being received being transmitted, through said transmitter, to an external device for processing by said system controller. In an embodiment additional to any of the above embodiments, the system controller is configured to use more than one system sensor to confirm any determination by said system controller of a need for the output control signal to be sent to said mechanism alert.
[0019] In a modality in addition to any of the above modalities, a pair of lenses is presented including the energized ophthalmic lens described above, in which the eye movement sensor system further includes a communication system for communication with at least one second contact lens, said second contact lens having an eye movement sensor system incorporated in the contact lens, the eye movement sensor system including at least one sensor to track and determine the position of an eye, and a conditioner. signal associated cooperatively with the sensor and configured to track and determine the position of the eye in spatial coordinates based on the information provided by the sensor output and provide an output motion signal; a system controller in electrical communication with said eye movement sensor, and a communication system for communicating the output of the eye movement sensor to said first contact lens. In addition to the previous mode, the system controller in said first contact lens detects divergences in the lines of sight of the user's eyes; said system controller sends the control signal to said alert mechanism. In addition to any of the previous modes, each lens also includes a backward facing pupil diameter sensor in communication
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13/114 electrical with said system controller, the said rear-facing pupil diameter sensor being used to measure the pupil diameter; said system controller of said second lens is configured to transmit said pupil diameter measurement by means of said communication systems to said system controller of said first lens, so that said system controller of the first lens is configured to determine whether the pupil dilations measured in the user's eye are substantially similar; when pupil dilations are different, the first system controller is configured to send the output control signal to said alert mechanism.
[0020] In at least one embodiment, the energized ophthalmic lens includes a contact lens; and a first sensor in said contact lens; at least a second sensor in said contact lens; a system controller in electrical communication with said first sensor and said at least one second sensor, said system controller having an associated memory containing a plurality of problem models and at least two sets of registers to store the data received from said sensors, said system controller being configured to compare the received sensor data with said plurality of problem models and generate a control signal when a match occurs, and at least one alert mechanism in electrical communication with the said system controller, said alert mechanism being configured to receive the output control signal and capable of at least one of the actions of providing an alert and storing the data. In another embodiment, the first sensor and / or said at least a second sensor are selected from a group consisting of an eyelid position sensor system, an eye movement sensor system, a biosensor, a bioimpedance sensor, a sensor
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14/114 temperature and a pulse oximeter. In an additional embodiment, at least one of the sensors described above is used as the first sensor and / or at least a second sensor in the previous two modes.
[0021] In at least one embodiment, an energized ophthalmic lens includes a contact lens; a light source facing the iris in said contact lens; at least one photosensor facing the iris arranged to receive reflected light around the eye, in which said light originates from said light source; and a system controller in electrical communication with said light source facing the iris and said at least one photosensor facing the iris, said system controller being configured to process at least one signal from said photosensor facing the iris and correlate the processed signal with at least one signal sent to said light source facing the iris. In another embodiment, the energized ophthalmic lens additionally includes a transmitter in electrical communication with said system controller, and said system controller is configured to send, through said transmitter, the correlated signals to an external device for processing. . In an additional modality to the other modalities of this paragraph, the light source facing the iris and the said at least one photosensor facing the iris are spaced from each other so that the said light source facing the iris and the said by the least one photosensor facing the iris are adjacent to opposite edges of said contact lens. In an embodiment additional to the other embodiments of this paragraph, the light source facing the iris includes a first light emitter that transmits a light having a wavelength of about 660 nm, and a second light emitter that transmits a light having a wavelength between about 890 nm and about 950 nm.
[0022] In at least one modality, a system to conduct
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15/114 a test protocol on a user of at least one contact lens includes a device that has a processor configured to execute a test protocol, a camera connected to said processor, a display connected to said processor and configured to display images generated by said processor, a communication module; and at least one energized ophthalmic contact lens having an eye movement sensor system that includes a sensor for determining and tracking the eye's position, said eye movement sensor being configured to provide the spatial location of the eye, a controller system associated cooperatively with the sensor, the system controller being configured to determine the movement of the eye based on the spatial location provided by the eye movement sensor system, said system controller being additionally configured to emit a signal control based on determination, and a communication circuit configured to facilitate communication with said communication module of said device during the execution of the test protocol; and said processor executing the test protocol in conjunction with said system controller. In another mode, the control signal generated by said system controller includes information about the direction of the gaze; said test protocol correlates the movement of said device performed by an individual while the display is providing directions to an individual with the direction of gaze received transmitted by said system controller through said communication circuit and said communication module, while if the movement of an individual's head is monitored, said processor being configured to trigger an alert to be shown on said display; and the directions being generated by said processor, based on instructions executed by said processor. In an additional modality to the previous modality, the device includes
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16/114 an accelerometer electrically connected to said processor, so that said processor is configured to use an output of said accelerometer in conjunction with an output of said camera to determine whether the individual's head is stable while said device is moved substantially in a straight line in front of the individual, and said processor is configured to correlate the accelerometer readings from said lens transmitted through said communication circuit and said communication module with the accelerometer signals from said accelerometer on said device; when a difference between the accelerometer signals after normalization for the distance covered by said device and said lens is greater than a threshold, then said processor is configured to trigger the alert to be shown on said display.
[0023] In a modality in addition to the first modality of the previous paragraph, the lens includes a pupil diameter sensor facing the iris in electrical communication with said system controller, said pupil diameter sensor facing the iris it is configured to provide a signal that represents the diameter of the pupil; said device additionally includes a light source controllable by said processor, and said test protocol includes activating said light source by said processor, measuring said pupil diameter by said system controller before and after activating the source of light, the transmission of said measurements by said system controller to said processor through said antennas, the comparison by said processor of said measurements to determine pupil dilation, and the sending by said processor of an alert to said display when at least one pupil dilation exceeds a dilation threshold and the pupil dilation is less than an undilated threshold. In another embodiment, the contact lens additionally includes a photodetector in communication with said
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17/114 system; and wherein said system controller is configured to use outputs from said photodetector to detect a light level from said light source. In a modality in addition to the first modalities of the previous paragraph, the lens additionally includes a pupil diameter sensor facing the iris in electrical communication with said system controller, and said pupil diameter sensor facing the iris is used to measure the diameter of the pupil; said device additionally includes a light source controllable by said processor, said test protocol including the display by said processor of instructions on said display that guide the user to look at a bright light, the measurement of said pupil diameter by said system controller before and after activation of the light source with said pupil diameter sensor, the transmission of said measurements by said system controller to said processor through said antennas, the comparison by said processor of said measurements to determine the pupil dilation, and the sending by said processor of an alert to said display when at least one pupil dilation exceeds a dilation threshold and the pupil dilation is less than an undilated threshold. In another embodiment, the contact lens additionally includes a photodetector in communication with said system controller; and wherein said system controller is configured to use outputs from said photodetector to detect a light level from said light source.
[0024] In a modality in addition to the modalities in the two previous paragraphs the sensor includes at least one accelerometer; and the test protocol is triggered by the detection of a possible concussion when said system controller determines that an acceleration of a user's head has exceeded a concussion threshold based on a signal received from said accelerometer. In an additional modality to the modalities in this paragraph and in the two previous paragraphs 870170039233, of 06/08/2017, p. 22/437
18/114 later, the test protocol includes making a lens wearer focus on a location on a stationary object, turning the wearer's head to the right or left while the wearer continues to look at the location, tracking the wearer's gaze in relation to the speed of rotation of the user's head to determine if the differential is within a predetermined threshold, alert the user through at least one of said alert mechanism and / or the transmission of an alert / signal to said device to display an alert on said display. In an additional embodiment, the eye movement sensor system includes at least one accelerometer; and the differential is determined based on a signal from said at least one accelerometer, in which a signal equal to zero indicates confirmation of the location tracking on the wall by the user, whereas a signal with a value other than zero indicates a delay on tracking the location on the wall. In a modality in addition to the two previous modalities, the test protocol additionally includes storing data from said test protocol in said device for later use in a verification study. [0025] In at least one mode, the system for conducting a test protocol on a user of at least one contact lens includes at least one energized ophthalmic contact lens having a configured pupil diameter sensor facing the iris to emit a signal that represents the diameter of the pupil; at least one photodetector facing forward; an alert mechanism; a system controller in communication with said iris-facing pupil diameter sensor and said at least one photodetector, the system controller being configured to monitor the outputs of said iris-facing pupil diameter sensor, monitor said at least one photodetector facing forward for a detected light that exceeds a brightness limit, compare the output of the pupil diameter sensor facing the iris before and after deposition 870170039233, from 06/08/2017, pg. 23/437
19/114 protection of light that exceeds the brightness threshold, and when the difference between the outputs of the pupil diameter sensor facing the iris exceeds an expansion threshold or is less than an undilated threshold, send a signal to said alert mechanism. In another mode, the user is alerted by the alert mechanism in response to the signal from the system controller.
BRIEF DESCRIPTION OF THE DRAWINGS [0026] The above, as well as other features and advantages of the present invention, will be evident from the more specific description, presented below, of the preferred modalities of the invention, as illustrated in the attached drawings.
[0027] Figures 1A to 1F illustrate a contact lens that has sensor systems, according to at least one embodiment of the present invention.
[0028] Figure 2A illustrates a diagrammatic representation of two eyelid position sensors that have a communication channel to synchronize the operation between two eyes, according to at least one embodiment of the present invention.
[0029] Figure 2B illustrates a diagrammatic representation of an eyelid position sensor that has a communication channel to communicate with an external device, according to at least one embodiment of the present invention.
[0030] Figures 3A to 3C illustrate flowcharts for medical monitoring methods according to the modalities of the present invention.
[0031] Figure 4 illustrates a graphical representation of light incident on the surface of the eye as a function of time, illustrating a possible pattern of involuntary blinking recorded at various levels of light intensity as a function of time, and a threshold level usable with based on some point between the maximum light intensity levels Petition 870170039233, 06/06/2017, p. 24/437
20/114 mo and minimum, according to at least one embodiment of the present invention.
[0032] Figure 5 is a state transition diagram of an eyelid position sensor system, according to at least one embodiment of the present invention.
[0033] Figure 6 illustrates a diagrammatic representation of a photodetection path used to detect and sample received light signals, according to at least one embodiment of the present invention.
[0034] Figure 7 illustrates a block diagram of digital conditioning logic, according to at least one embodiment of the present invention.
[0035] Figure 8 illustrates a block diagram of digital detection logic, according to at least one embodiment of the present invention.
[0036] Figure 9 illustrates a time diagram, according to at least one embodiment of the present invention.
[0037] Figure 10 illustrates a diagrammatic representation of a digital system controller, according to at least one embodiment of the present invention.
[0038] Figures 11A to 11G illustrate time diagrams for automatic gain control, according to at least one embodiment of the present invention.
[0039] Figure 12 illustrates a diagrammatic representation of light blocking and light passing regions in an integrated circuit matrix, according to at least one embodiment of the present invention.
[0040] Figure 13 illustrates a diagrammatic representation of an electronic insertion element, which includes a blink detector, for a contact lens energized according to at least one
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21/114 embodiment of the present invention.
[0041] Figures 14A and 14B illustrate diagrammatic representations of eyelid position sensors, according to at least one embodiment of the present invention.
[0042] Figure 15A illustrates a diagrammatic representation of an electronic system incorporated into a contact lens to detect the position of the eyelid according to at least one embodiment of the present invention.
[0043] Figure 15B illustrates an enlarged view of the electronic system of Figure 15A.
[0044] Figure 16 illustrates a diagrammatic representation of the outputs of the eyelid position sensors, according to at least one embodiment of the present invention.
[0045] Figure 17A illustrates a diagrammatic representation of another electronic system incorporated into a contact lens to detect the position of the eyelid, according to at least one embodiment of the present invention.
[0046] Figure 17B illustrates an enlarged view of the electronic system of Figure 17A.
[0047] Figures 18A to 18C illustrate diagrammatic representations of an eyelid position detector system, according to at least one embodiment of the present invention.
[0048] Figure 18D illustrates an enlarged view of the electronic system of Figures 18A to 18C.
[0049] Figure 19A illustrates a diagrammatic representation of a position detection and convergence system of the exemplifying pupil incorporated into a contact lens, according to at least one embodiment of the present invention.
[0050] Figure 19B is an enlarged view of the position detection and convergence system of the pupil of Figure 19A.
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22/114 [0051] Figure 19C illustrates an overlap of X, Y and Z axes in the eye.
[0052] Figure 20 illustrates a diagrammatic representation of two position sensors and eyelid convergence that have a communication channel to synchronize the operation between two eyes, according to at least one embodiment of the present invention.
[0053] Figure 21 illustrates a diagrammatic representation of a plot of the correlation between pupil convergence and focal length.
[0054] Figure 22A illustrates a diagrammatic representation in anterior perspective of an individual's eyes looking to the right. [0055] Figure 22B illustrates a diagrammatic representation in top perspective of the eyes of Figure 22A.
[0056] Figure 23 illustrates a diagrammatic representation of geometry associated with several directions of looking in two dimensions, according to at least one embodiment of the present invention.
[0057] Figure 24 illustrates a diagrammatic representation of an energized ophthalmic lens that has a first pupil diameter sensor positioned in one eye, according to at least one embodiment of the present invention.
[0058] Figure 25 illustrates a diagrammatic representation of an energized ophthalmic lens that has a second pupil diameter sensor positioned in one eye, according to at least one embodiment of the present invention.
[0059] Figure 26 illustrates a graph of an example of ambient light and pupil diameter as a function of time.
[0060] Figure 27 illustrates a diagrammatic representation of an energized ophthalmic lens that has pulse oximetry components, in accordance with at least one embodiment of the present invention. [0061] Figure 28 illustrates a diagrammatic representation of a
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23/114 energized ophthalmic lens having pulse oximetry components, in accordance with at least a second embodiment of the present invention.
[0062] Figure 29 illustrates a block diagram of a sensor insertion modality according to at least one embodiment of the present invention.
[0063] Figure 30 illustrates a block diagram of a generic system that has multiple sensors, a system controller and an alert mechanism, and an activation decision is made based on the output of two or more sensors, according to with the present invention.
[0064] Figure 31 illustrates a flowchart of a method by which a system controller determines whether the state of an alert mechanism should be changed based on sensor inputs, in accordance with at least one embodiment of the present invention. [0065] Figure 32 illustrates a block diagram of a storage box, according to at least one embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERENTIAL MODALITIES [0066] Conventional contact lenses are polymeric structures with specific shapes to correct various vision problems, as briefly presented above. For improved functionality, various circuits and components can be integrated into these polymeric structures. For example, control circuits, microprocessors, communication devices, power supplies, sensors, actuators, light-emitting diodes and miniature antennas can be integrated into contact lenses through custom optoelectronic components, not only to correct vision, but to improve vision and also provide additional functionality, as explained here. Electronic contact lenses
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24/114 and / or energized can be designed to provide enhanced vision through enlargement and reduction features, or simply by modifying the refractive capabilities of the lens. Electronic and / or energized contact lenses can be designed to improve color and resolution, display text information, translate speech into subtitles in real time, offer visual cues from a navigation system, and provide image processing and internet access. The lenses can be designed to allow the user to see in low light conditions. Electronic elements and / or the disposition of electronic elements properly projected on the lenses can make it possible to project an image onto the retina, for example, without a variable focus optical lens, provide innovative image displays and even provide wake-up alarms. In addition, sensors integrated into the lens can be used to detect incident light in the eye to compensate for ambient light conditions, or for use in determining blink patterns and whether the user is asleep or awake.
[0067] The energized or electronic contact lens of at least one exemplary modality includes the elements necessary to monitor the user, with or without elements to correct and / or improve the vision of patients with one or more of the vision defects described above or , otherwise, perform a useful ophthalmic function. The electronic contact lens can have a variable focus optical lens, a front optical element included in a contact lens, or simply electronic insertion elements without a lens for any suitable functionality. The electronic lens of the present invention can be incorporated into any number of contact lenses, as described above. In addition, intraocular lenses can also incorporate the various components and features described here. However, for ease of explanation, the description
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11/25 will focus on an electronic contact lens designed to be discarded daily after single use.
[0068] The present invention can be used in an energized ophthalmic lens or in an energized contact lens having an electronic system, which activates an optical element with variable focus or any other one or more devices configured to implement any number among numerous functions that can be accomplished. The electronic system includes one or more batteries or other power sources, energy management circuits, one or more sensors, clock generation circuits (clock), control algorithms and circuits and lens drive circuits. The complexity of these components can vary, depending on the required or desired functionality of the lens. Alternatively, the contact lens can only monitor the user in at least one mode.
[0069] The control of an electronic or energized ophthalmic lens can be obtained through an external device operated manually that communicates with the lens, such as a portable remote unit, a storage container or a cleaning box. For example, a fob switch can communicate wirelessly with the powered lens based on user input. Alternatively, control of the energized ophthalmic lens can be achieved through retrain information or control signals directly from the user. For example, sensors embedded in the lens can detect blinks, blink patterns, eyelid closure and / or eye movement. Based on the pattern or the sequence of blinks and / or movement, the energized ophthalmic lens can change the operating state. Another alternative is that the user has no control over the operation of the energized ophthalmic lens. In at least one mode, the lens control can be used to 1) initiate
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26/114 a medical monitoring session and / or protocol test and / or 2) tag and / or store sensor data. In at least one embodiment, these lens controls are examples of input means for receiving input entered by the user.
[0070] In at least one exemplary embodiment, the contact lens includes at least one sensor 110 in electrical communication with a system controller 130 to allow user monitoring of the contact lens and / or alert the user when a medical condition occurs At least one sensor is detected. In another example, there are at least two sensors 110 ', 120' (110, 120) that monitor the user of the contact lens 100A to 100F, as shown in Figures 1A to 1F. Examples of sensors as will be further developed in this disclosure include: an eyelid position sensor system, an eye movement sensor system, a pupil diameter sensor, a bioimpedance sensor, a pulse oximeter, a salinity sensor, a biosensor, stress and / or pressure sensors and a temperature sensor. [0071] System controller 130 in at least one example embodiment uses at least one predetermined threshold to compare at least one sample of data from at least one sensor to determine whether a medical condition has arisen. In another exemplary embodiment, system controller 130 makes use of at least one problem model (or standard) with which a series of data samples, or alternatively, a data sample from at least one sensor is compared to determine if a medical condition arose, for example, based on a match with the pattern and / or a threshold being reached, exceeded or less, resulting in the problem model being satisfied. In at least one example, the problem model includes only at least one threshold. In an alternative exemplifying modality, both
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27/114 thresholds as defaults are used by system controller 130. In at least one example embodiment, as illustrated in Figure 1A, system controller 130 is in electrical communication with a data store 132 that stores the threshold (or thresholds) and / or model (or models). In at least one exemplary embodiment, a plurality of problem models can include any combination of patterns and thresholds. Examples of data storage 132 include memory such as persistent or non-volatile memory, volatile memory and buffer memory, a register (or registers), a cache (or caches), programmable read-only memory (PROM) and flash memory.
[0072] The system in Figure 1A also includes an alert mechanism 150 that receives output from system controller 130. Alert mechanism 150 can include any device suitable for implementing a specific alert for the user, based on a command signal received from system controller 130. For example, if a set of sample data matches a problem model, system controller 130 can activate alert mechanism 150, such as a light (or light matrix) ) to pulse a light or cause a physical wave to pulse on the user's retina (or alternatively through the lens) or to record data regarding the user's state. Additional examples of the alert mechanism 150 include an electrical device; a mechanical device including, for example, piezoelectric devices, transducers, vibrating devices, chemical release devices with examples that include the release of chemicals to cause an itch, irritation or burning sensation and acoustic devices; a transducer that provides modification of the optical zone of an optical zone of the contact lens, such as modifying the focus and / or percentage of light transmission through the lens; a magnetic device; an electroPetition device 870170039233, from 06/08/2017, p. 32/437
28/114 magnetic; a thermal device; an optical staining mechanism with or without liquid crystal, prisms, optical fiber, and / or light tubes, for example, to provide optical modification and / or direct light towards the retina; an electrical device such as an electrical stimulator to provide a stimulus of the middle retina or to stimulate at least one of a corneal surface and one or more corneal sensory nerves; or any combination thereof. In an alternative exemplary embodiment, alert mechanism 150 sends an alert to an external device. Alert mechanism 150 receives a signal from system controller 130 in addition to power from power source 180 and produces some action based on the signal from system controller 130. For example, if the output signal from system controller 130 occurs during an operating state, then alert mechanism 150 can alert the user that a medical condition has arisen. In an alternative embodiment, if the output signal emitted by the system controller 130 occurs during another operating state, then the mechanism 150 will record the information in memory for later retrieval. In yet another alternative exemplary embodiment, the signal will cause the alert mechanism 150 to emit an alarm to store the information. In an alternative exemplary embodiment, system controller 130 stores data in memory (for example, data storage 132) associated with system controller 130 and does not use alert mechanism 150 for data storage, and in at least one For example, the alert mechanism 150 is omitted from the illustrated modalities of Figures 1A to 1F. In at least one exemplary embodiment, there is a clock as a timing circuit 140 in Figure 1D that is capable of providing a date and time stamp. As shown above, the powered lens of the present invention can provide several features; consequently,
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29/114 one or more alert mechanisms can be configured in a variety of ways to implement the functionality.
[0073] Figure 1A also illustrates a power source 180 that supplies power to various components in the system. Energy can be supplied from a battery, a power collector, or other suitable means as is known to the person skilled in the art. Essentially, any type of power source 180 can be used to provide reliable power for all other components in the system. In an alternative exemplary modality, the communication functionality is provided by an energy collector that acts as the receiver for the time signal, for example, in an alternative modality, the energy collector is a solar cell or radio frequency (RF) receiver. ), which receives both energy and a signal (or indication) from the time base. In another alternative example, the energy collector is an inductive charger, in which energy is transferred, in addition to data such as RFID. In one or more of these alternative modalities, the time signal can be inherent in the energy collected, for example, in N * 60 Hz of inductive load or lighting.
[0074] In at least one exemplary embodiment, as shown in Figure 1B, system controller 130 includes a register 134 for storing data samples from at least one sensor 110/120. In another example, there is an individual recorder for each sensor present in the contact lens used to monitor a medical condition. In yet another example, there is an individual recorder for each sensor present in the contact lens. The use of a recorder in at least one modality allows the comparison of data with a problem model with or without a mask. In an alternative example mode, another data store is used
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30/114 instead of a registrar (or registrars). In an alternative embodiment, register 134 is part of data store 132.
[0075] Figure 1B also illustrates a medical monitoring system, according to at least one exemplary modality. The illustrated system includes a 100B contact lens having an eyelid position sensor system 110, an eye movement sensor system 120, a system controller 130 and an alert mechanism 150. The sensor systems 110, 120 are in electrical communication with the system controller 130, which, in turn, is in electrical communication with the alert mechanism 150. In at least one embodiment, the alert mechanism 150 includes an accumulator connected to a memory. In at least one embodiment, the alerting mechanism 150 is consolidated with the system controller 130. Figure 1B also illustrates a power source 180 that, in at least one embodiment, supplies power to the other components of the system. Figure 1B illustrates an optional resource management system 160, which will be discussed later.
[0076] Figure 1C illustrates, in the form of a block diagram, a 100C contact lens according to at least one exemplary modality. In the illustrated embodiment, the contact lens 100C includes an eyelid position system 110, an eye movement sensor system 120, a system controller 130, an alert mechanism 150 and a power source 180.
[0077] The eyelid position sensor system 110 illustrated in Figure 1C includes at least one sensor in electrical communication with one or more signal processing components. The at least one sensor makes it possible to detect the closure of the eyelid and can take a variety of forms, as is discussed later in this disclosure. The illustrated eyelid position system 110 includes a
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31/114 photosensor 112, an amplifier 114, an analog-to-digital converter (or ADC) 116 and a digital signal processor 118.
[0078] The eye movement sensor system 120 illustrated in Figure 1C includes at least one sensor in electrical communication with a signal processor. The at least one sensor can take a variety of forms, as is discussed later in this disclosure. Examples include an accelerometer and a transducer. The illustrated eye motion sensor system 120 includes a sensor 122 and a signal processor 124 as a capture sampling signal conditioner.
[0079] In an alternative modality, an integrated circuit or other electrical component that houses the system controller also houses the signal processing of the two sensor systems.
[0080] When the 100C contact lens is placed on the front surface of a user's eye, the electronic circuit of the blink detector system can be used to implement blink detection in at least one example mode. Photosensor 112, like other circuits, is configured to detect blinks, various blink patterns produced by the user's eye, and / or eyelid closure level.
[0081] In this exemplary modality, photosensor 112 can be embedded in the 100C contact lens and receives ambient light 141, converting incident photons into electrons and, thus, causing a current, indicated by the arrow 113, to flow into the amplifier 114 The photosensor or photodetector 112 can include any suitable device. In an exemplary embodiment, photosensor 112 includes a photodiode. In one embodiment, the photodiode is implemented in a complementary metal oxide semiconductor (CMOS processing technology) to increase the integration capacity and reduce the overall size of photosensor 112 and the other circuit. THE
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32/114 current 113 is proportional to the level of incident lighting and decreases substantially when photodetector 112 is covered by an eyelid. Amplifier 114 creates an output proportional to the gain, and can function as a transimpedance amplifier that converts the input current into an output voltage. Amplifier 114 can amplify a signal to a level usable by the rest of the system, as giving the signal enough voltage and energy to be captured by the ADC 116. For example, amplifier 114 may be needed to target subsequent blocks, since the output Photosensor 112 can be very small and can be used in low light environments. Amplifier 114 can be implemented as a variable gain amplifier, the gain of which can be adjusted by system controller 130, in a feedback arrangement, to maximize the dynamic range of the system. In addition to the gain supply, amplifier 114 can include another analog signal conditioning circuit, such as filtration and another circuit suitable for the outputs of photosensor 112 and amplifier 114. Amplifier 114 can include any device suitable for amplification and conditioning of the signal output by photosensor 112. For example, amplifier 114 may include a single operational amplifier or a more complicated circuit comprising one or more operational amplifiers. Photosensor 112 can be a switchable array of photodiodes, and amplifier 114 can be an integrator. As shown above, photosensor 112 and amplifier 114 are configured to detect and isolate blink sequences based on the intensity of incident light received through the eye and convert the input current into a digital signal usable by the system controller. 130. In at least one mode, system controller 130 is preferably programmed or pre-configured to recognize multiple flash sequences, paPetition 870170039233, 06/06/2017, p. 37/437
33/114 blink patterns and / or eyelid closures (partial or complete) at various levels of light intensity, and enable adequate control of the contact lens and / or a suitable output signal for the 150 warning mechanism. At least In one embodiment, system controller 130 also includes an associated memory.
[0082] In this exemplary embodiment, ADC 116 can be used to convert a continuous analog signal output from amplifier 114 into a suitable sampled digital signal for further signal processing. For example, ADC 116 can convert an analog signal output from amplifier 114 to a digital signal that can be used by subsequent circuits or downstream, such as a digital signal processor 118. Digital signal processor 118 can be used for digital signal processing, including one or more of filtering, processing, detection and otherwise sampled manipulation / processing data to allow detection of incident light for downstream use. The digital signal processor 118 can be pre-programmed with the blink sequences and / or blink patterns described above with a blink sequence that indicates prolonged eyelid closure or eyelid deviation. The digital signal processor 118, also in at least one example mode, includes an associated memory, which in at least one mode stores the model and mask sets to detect, for example, flash patterns for each operating state as selected by the system controller 130. The digital signal processor 118 can be implemented using an analog circuit, digital circuit, software, or a combination thereof. In the illustrated modality, it is implemented in a digital circuit. The ADC 116 together with the amplifier 114 and the associated digital signal processor 118 are activated at an appropriate rate in accordance with the sampling rate previously
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34/114 described, for example, every hundred (100) ms, which is subject to adjustment in at least one exemplary modality.
[0083] In at least one exemplary embodiment, any suitable device that allows detection of movement of the eye and, more particularly, of the pupil can be used as sensor 122, and more than a single sensor 122 can be used. The output of sensor 122 is captured, sampled, and conditioned by signal processor 124. Signal processor 124 can include several devices including an amplifier, transimpedance amplifier, analog-to-digital converter, filter, digital signal processor , and related circuits to receive data from sensor 122 and generate an output in a format suitable for the rest of the system. Signal processor 124 can be implemented using an analog circuit, a digital circuit, software, and / or a combination thereof. In at least one exemplary embodiment, signal processor 124 is co-designed with sensor 122, for example, circuits for capturing and conditioning an accelerometer are different from circuits for a muscle activity sensor or optical pupil tracker. The output of signal processor 124, in at least one exemplary mode, is a sampled digital current and may include an absolute or relative position, movement, gaze detected in agreement with convergence, or other data. System controller 130 receives input from position signal processor 124 and uses this information, in conjunction with input from the eyelid position sensor system, to monitor the user. [0084] In at least one embodiment, signal processors 118 and 124 are combined in (or manufactured as) a signal processor.
[0085] Additionally, system controller 130 can control other aspects of an energized contact lens depending on
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35/114 of the input of digital signal processor 118 and / or signal processor 124, for example, changing the focus or refractive power of an electronically controlled lens via an actuator.
[0086] In at least one example mode, system controller 130 will determine the operating status of the lens based on a received flash pattern, for example, to start or stop monitoring, although in an alternative mode, other states of operation are possible simultaneously or separately. In addition or alternatively to this mode, the operating state will determine a set of flashing and masking models to be used by the digital signal processor 118 in this operating state with control over what the data manager 150 does in response to an output of system controller 130 when detecting that the user has a medical condition.
[0087] System controller 130 uses the signal from the photosensor chain; namely, photosensor 112, amplifier 114, ADC 116 and digital signal processing system 118, to compare levels of sampled lighting to determine eyelid closure and / or blink activation patterns.
[0088] Figure 1D illustrates the system represented in Figure 1A, where a contact lens 100D additionally includes a timing circuit 140. Timing circuit 140 provides a clock signal for operation of electronic components in contact lenses that require a clock sign. Timing circuit 140 in at least one example embodiment includes an accumulator 142 for tracking the passage of time. An example of an accumulator is a recorder acting as an accountant. In an alternative exemplary modality, accumulator 142 is adjusted to an approximate value in time, in the future, when the alarm must be provided to the user, and works in countdown from that value,
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36/114 which causes system controller 130 to perform a reading comparison to zero, to determine when to send the alert signal. In alternative exemplifying modalities, timing circuit 140, as illustrated in contact lens 100E in Figure 1E, can include an oscillator 144 having a crystal, for example, quartz, a resistor-capacitor (RC), an inductor-capacitor ( LC) and / or relaxation circuits. In another example, the frequency of the oscillator is maintained by a variable capacitor including a selectable capacitor arrangement, a varactor diode, and / or a variable resistor. In at least one example mode, a recorder in electrical communication with the oscillator is adjusted, and the contents of the recorder are then decoded to provide adjustment of variable components that lead to the adjustment of the oscillator frequency.
[0089] Figure 1F illustrates the system represented in Figure 1A where a contact lens 100F additionally includes a communication circuit 170. Communication circuit 170 facilitates communication between system controller 130 and another contact lens (as discussed, for example, in connection with Figure 2A) and / or an external device (as discussed, for example, in connection with Figure 2B). Examples of the external device include a fob, a cell phone, a smartphone, a smartwatch, a computer, and a mobile computing device including a tablet. The communication circuit 170 in at least one example embodiment includes an antenna and a receiver. In another alternative exemplary embodiment, the communication circuit 170 may include a transmitter in addition to the receiver or a transceiver. In another alternative exemplary modality, communication circuit 170 facilitates communication via radio frequency (for example, Bluetooth, ANT or a custom protocol), sonic, ultrasonic and light. A possible sonic / ultrasonic approach would be to use a loudspeaker 870170039233, of 06/08/2017, p. 41/437
37/114 speaker (for example, a speaker on a smartphone) to provide an audio signal to a transducer or other receiver on the lens. A possible approach to light other than a fob is to use a display (for example, smart phone display, tablet display, computer display or a television) to introduce a subliminal flash containing data for the lens to receive. In at least one example mode, the communication circuit 170 and / or the eyelid position sensor system are examples of user input, which, in at least one example mode, is used to activate the system controller 130 to store data and / or mark data.
[0090] In at least one exemplary embodiment, the timing circuit 140, the resource management system 160 and the communication circuit 170 can be used in different combinations with the other elements including at least one sensor and with each other.
[0091] Figure 2A illustrates a system in which two eyes 280 are partially covered with contact lenses 200. Sensor arrays 210 are present on both contact lenses 200 to determine the position of the eyelid (s) , as described with reference to Figures 14A to 15B and 17A to 18B, subsequently. In this exemplary embodiment, contact lenses 200 each include an electronic communication component 270, which is an example of a communication circuit 170 in Figure 1F. The electronic communication component 270 in each contact lens 200 allows bidirectional communication to occur between contact lenses 200. Electronic communication components 270 can include transmitters, receivers, radio frequency (RF) transceivers, antennas, interface circuits for photosensors 212 comprising arrangements of sensors 210 and associated electronic components or
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38/114 similar. The communication channel represented by line 275 may include RF transmissions at the appropriate frequency and power, with an appropriate data protocol to allow effective communication between contact lenses 200. Data transmission between the two contact lenses 200 can, for example, checking that both eyelids closed in order to detect a real purposeful blink instead of an involuntary blink or blink. Transmission can also allow a system to determine whether both eyelids closed in a similar way, for example, as in a situation where a user reads a text close to the eyes; the pupils are substantially the same size; and / or the look direction of the eyes. Data transmission 275 can also occur to and / or to a communication component 292 on an external device 290, for example, glasses, or a smartphone (or other processor-based system), as illustrated, for example, in Figure 2B . In at least one embodiment, electronic communication components 270, for example, allow you to transmit data to and receive a response from the smartphone (or other external device) 290 that has a communication component 292. Thus, electronic communication components 270 can be present in only one lens in at least one alternative mode.
[0092] Figures 3A and 3B are flowcharts that illustrate methods for medical monitoring with an energized ophthalmic lens. As discussed in this disclosure, there are several ways to activate the energized 302 ophthalmic lens. In at least one example mode, when a timing circuit that provides a time is not present and in response to activation of the energized ophthalmic lens, an accumulator is started on the lens to track a 304 time pass. The system controller monitors at least one sensor at a first 306 sample rate. The system controller
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39/114 determines whether the output (s) of the sensor (s) exceeds / correspond to a limit 308. In at least one example mode, when the limit is exceeded or the combined pattern (matched) ), this is an indication that a medical condition has occurred and the system controller sends a signal to the 310 warning mechanism. Otherwise, the sensor is still being monitored. Continuing the process in Figure 3A, the mechanism activates an alarm 312. Examples of alarms are as discussed earlier in this disclosure. In at least one example mode, the alarm continues as long as the method returns to additional user monitoring. In an alternative embodiment, the alarm step continues until it receives a stop instruction and / or a determination that the medical condition has decreased.
[0093] Figure 3B is identical to the method in Figure 3A, but continues the process by making the alert mechanism store data related to medical condition 312 '. Examples of data storage include recording the current sensor data, storing the contents of a buffer or register containing the current and recent sensor data and storing a threshold value if the threshold is adjustable. Data storage can be done with or without a date and time stamp, for example, the accumulator or the timing circuit. In at least one example, the method returns to additional user monitoring.
[0094] In an alternative exemplary modality, the standard is used to predict when a medical condition is about to begin to provide an alert to the user informing of the impending medical condition to allow the user to take appropriate measures before the condition occurs doctor. In another alternative example mode, the alert can be delivered to another device. An example where this would be useful is the situation
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40/114 where the user suffers from seizures, in which the alarm would give the person time to assume a predetermined position, insert an implement in the mouth, inform someone nearby, or another action to better protect themselves during the seizure.
[0095] Figure 3C illustrates an alternative method of medical monitoring with an energized ophthalmic lens. As discussed in this disclosure, there are several ways to activate the energized 302 ophthalmic lens. In at least one example mode, when a timing circuit that provides a time is not present and in response to activation of the energized ophthalmic lens, an accumulator is started on the lens to track a time span 304. The system controller monitors at least one sensor at a first 306 sample rate. The system controller stores the reading of at least one sensor in one or more 328 buffers. The system controller , upon receiving a dialing instruction, 330, copies the contents of one or more buffers to the data store with or without the use of the alert mechanism along with a 332 timestamp. The timestamp can be obtained, for example, from the accumulator or from the timing circuit. In at least one example, the method returns to additional monitoring of at least one sensor.
[0096] Based on this disclosure, it should be understood that any of the methods presented here can additionally include a termination step based on an instruction, for example, from the user; a resource management system, etc. In an alternative exemplary modality, the limitation of an accumulator is omitted when timestamps are not desired for a specific implementation.
[0097] With reference to Figure 4, a graphical representation of the blink pattern samples recorded at various levels is illustrated. 870170039233, of 06/08/2017, p. 45/437
41/114 levels of light intensity as a function of time and a usable threshold level. Consequently, it can be taken into account that several factors can mitigate and / or avoid error in the detection of blinks when sampling the light that strikes the eye, such as when taking into account changes in light intensity levels in different locations and / or while carrying out various activities. Additionally, when incident light samples are taken in the eye, taking into account the effects that changes in ambient light intensity can have on the eye and eyelid can also mitigate and / or prevent errors in the detection of blinks, such as the amount of light a visible eyelid blocks when it is closed in low light levels and high light levels. In other words, in order to prevent the wrong blink patterns from being used for the control, the level of ambient lighting is preferably taken into account, as explained in more detail below.
[0098] For example, in one study, it was found that the eyelid blocks, on average, approximately ninety (99) percent of visible light, but at lower wavelengths less light tends to be transmitted through the eyelid, blocking approximately 99.6 percent of visible light. At longer wavelengths, towards the infrared portion of the spectrum, the eyelid can block only thirty (30) percent of the incident light. What is important to note; however, it is that light at different frequencies, wavelengths and intensities can be transmitted through the eyelids with different efficiencies. For example, when looking at a bright light source, an individual may see red light with his eyelids closed. There may also be variations in the amount of visible light that an eyelid blocks, based on the individual, such as the individual's skin pigmentation. As shown in Figure 4, samples of blink pattern data along
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42/114 various levels of illumination are simulated over a time interval of seventy (70) seconds, with the levels of visible light intensity transmitted through the eye being recorded during the stimulus period, and a usable threshold value is illustrated . The threshold is adjusted to a value between the peak-to-peak value of the visible light intensity recorded for blink patterns sampled over a stimulus period at different light intensity levels. The ability to pre-program blink patterns while tracking an average light level over time and adjusting a threshold can be critical to the ability to detect when an individual is blinking, as opposed to when an individual is not blinking and / or there is only a change in the level of light intensity in a certain area.
[0099] In at least one example mode, the system controller uses a blink detection method to detect blink characteristics, for example if the eyelid is open or closed, the blink duration, the blink interval, and the number flashes in a given period of time. In at least one exemplary modality, the blink detection method is based on sampling the light incident on the eye at a certain sampling rate. Predetermined blink patterns are stored and compared to the recent history of incident light samples. When the patterns match, the blink detection method can trigger an activity in the system controller, for example, start a test, start a monitoring session, mark and / or store data and / or change the operation of the lens. The blink detection method in at least one exemplary mode further distinguishes between predetermined blink patterns and eyelid movements associated with a medical condition, drowsiness, falling asleep or sleep.
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43/114 [0100] Blinking is the rapid opening and closing of the eyelids, being an essential function of the eye. Blinking protects the eye from foreign objects, for example, individuals blink when objects appear unexpectedly in the vicinity of the eye. The blinking provides lubrication on the anterior surface of the eye, through the dispersion of tears. Blinking also serves to remove contaminants and / or irritants from the eye. Usually, the blinking is done automatically, but external stimuli can contribute, as in the case of irritants. Spontaneous blinking is a function of the individual and remains constant if the environment does not change. On average, an individual blinks 12 to 15 times a minute. However, when someone is excited, the number of blinks increases, as well as when someone is bored. On the other hand, in a state of concentration, an individual's blink rate decreases substantially. Individuals also have blink reflexes; that is, a tactile reflex, an optical reflex, a blinding reflex, an auditory reflex and a threat reflex. These blink reflexes will be discussed in more detail later. However, the blink can also be purposeful; for example, individuals who are unable to communicate verbally or with gestures may blink once for yes and twice for no. The blink detection method and system of at least one exemplary modality uses blink patterns that cannot be confused with the normal blink response. In other words, if the blink is used as a means to control an action, then the particular pattern selected for a given action cannot occur at random; otherwise, inadvertent actions may occur. As the speed and / or frequency of blinking can be affected by several factors, including fatigue, concentration, boredom, eye damage, medications and illnesses, blink patterns for control purposes take these and any other preference into account.
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44/114 variables that affect the blink. The average duration of involuntary blinks is in the range of about one hundred (100) to four hundred (400) milliseconds. Average male or female adults blink at a rate of ten (10) involuntary blinks per minute, and the average time between involuntary blinks is about 0.3 to seventy (70) seconds. The movements of the eyelids may also indicate other conditions such as drowsiness, as the eyelids have a general tendency to close over a period of time, or remain closed for a period of time, which indicates that the user is sleeping.
[0101] An example of a blink detection method can be summarized in the following steps:
1. Define an intentional blink sequence that will be performed by the user to detect positive blink or that is representative of sleep onset.
2. Sample the level of incident light at a rate consistent with detecting the blink sequence and rejecting unintentional blinks.
3. Compare the history of the light levels sampled to the expected flash sequence, as defined by a flash value model.
4. Optionally, implement a blink mask sequence to indicate portions of the model to be ignored during comparisons, for example, near transitions. This can allow a user to deviate from a desired blinking sequence, such as an error window of plus or minus one (1), and one or more of the lens activation, control, and change of focus may occur. In addition, this may allow variation in the timing of the user's flashing sequence. In another example, the concept of patterns and masks is applied to other
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45/114 sensor data to detect a medical condition using problem patterns and masks. In another exemplary modality, the standard is a model that in at least one modality includes at least one limit.
[0102] A sequence of blinks can be defined as shown below:
1. blink (closed) for 0.5 s
2. open for 0.5 s
3. blink (closed) for 0.5 s [0103] At a sample rate of one hundred (100) ms, a blink model of twenty (20) samples is given by:
blinktemplate = [1,1,1, 0,0,0,0,0, 1,1,1,1,1, 0,0,0,0,0, 1,1].
[0104] The blink mask is set to mask out samples just after a transition (0 to mask out or skip samples), and is given by blink_mask = [1,1,1, 0,1,1,1 , 1, 0,1,1,1,1, 0,1,1,1,1, 0,1].
[0105] Optionally, a wider transition region can be eliminated by masking to allow for greater timing uncertainty, and is given by blinkmask = [1,1,0, 0,1,1,1,0, 0,1, 1.1.0, 0.1.1,1.0, 0.1].
[0106] Alternative standards can be implemented, for example a single long blink, in this case, a 1.5 s blink with a 24-sample model, given by
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46/114 blinktemplate = [1,1,1,1,0,0, 0,0,0,0,0,0, 0,0,0,0,0,0, 0,1,1,1, 1.1].
[0107] An additional alternative pattern can be implemented as an indicative of sleep, in this case a blink of 2.4 s (or eyes that closed to sleep) with a model of 24 samples, given by blink template = [0.0, 0,0,0,0, 0,0,0,0,0,0, 0,0,0,0,0,0, 0,0,0,0,0,0].
[0108] In an alternative modality, this blink template is used without a blinkmask.
[0109] It is important to note that the examples above are for illustrative purposes and do not represent a specific set of data.
[0110] Detection can be implemented by logically comparing the sample history to the model and the mask. The logical operation is a unique OR (XOR) operation between the model and the sample history sequence, bit by bit, and then verifying that all the unmasked history bits match the model. For example, as illustrated in the mask samples above, at each location in the sequence of a mask where the value is logical 1, a blink needs to match (match) with the mask model at that location in the sequence. However, at each location in the sequence of a mask where the value is logical 0, it is not necessary for a blink (or other sensor state) to match (match) with the mask model at that location in the sequence. For example, the following Boolean algorithm equation can be used, as coded in MATLAB® (MathWorks, Natick, Massachusetts, USA).
combined = no (mask) | no (xor (template, test_sample)),
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47/114 where test_sample is the sample history. The combined value is a string with the same length as the model, sample history and mask. If the combined sequence is all made up of logical 1’s, then a good match has occurred. In short, no (xor (template, test_sample)) results in a logical 0 for each combination error and a logical 1 for each combination. The application of the logical OR with the mask inverted forces each location in the sequence corresponding to a logical 1 when the mask is logical 0. Consequently, the more locations in a mask model where the value is specified as logical 0, the greater the margin of error allowed in relation to a person's blinking (or other sensor state). It is also important to note that the greater the number of logical 0’s in the mask model, the greater the potential for false positives corresponding to the expected or intended blink patterns. It should be understood that a variety of expected or intended patterns can be programmed into a device with one or more assets at a time, and in at least one mode to control the use of specific patterns to be used in a specific operating state. More specifically, multiple expected or intended patterns can be used for the same purpose or functionality, or to implement different or alternative functionality. For example, a pattern can be used to cause the lens to change its operating state, end monitoring and / or start monitoring. In at least one mode, blink detection can also detect when the eyelids remain closed, which would be detected as a continuous blink.
[0111] Figures 5 to 18D provide examples of eyelid position sensor systems (or blink detection sensor systems). In at least one exemplary modality, the eyelid position sensor systems use blink detection for petition 870170039233, from 06/08/2017, p. 52/437
48/114 finish if the eyelid is closed, and if it remains closed over a period of time.
[0112] Figure 5 illustrates a state transition diagram 500 for a blink detection system according to at least one modality. The system starts in an IDLE 502 state waiting for a bl_go activation signal to be expressed. When the activation signal bl_go is expressed, for example, by an oscillator and a control circuit that pulsates bl_go at a rate of one hundred (100) ms in proportion to the blink sample rate, the state equipment then changes to an AGUARDEADC state. 504 in which an ADC is activated to convert a received light level to a digital value. The ADC evaluates the adc_done signal to indicate that its operations are complete and the state system or equipment changes to a 506 SHIFT state. In the 506 SHIFT state the system places the most recently received ADC output value in a shift register to keep the history of the blink samples. In some embodiments, the output value of the ADC is first compared to a threshold value to provide a single bit (1 or 0) for the sample value, in order to minimize storage requirements. The state system or equipment then changes to a COMPARATE 508 state in which the values of the sample history shift register are compared to one or more models and masks of the flash sequence, as described above. If a combination is detected, one or more output signals can be expressed, for example, to switch the state of the lens to a sleeping state of operation or an awake state of operation or to signal the start of the user's sleep. The state system or equipment then changes to the FINISHED 510 state and expresses a bl_done signal to indicate that its operations are complete.
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49/114 [0113] Figure 6 illustrates a signal path of the photosensor or photodetector pd_rx_top that can be used to detect and take samples of the received light levels. The signal path pd_rx_top can include a photodiode 602, a transimpedance amplifier 604, an automatic gain and low pass filtering stage 606 (AGC / LPF), and an ADC 608. The signal adc_vref is supplied to ADC 608 from power source 620 (see power supply 180 in Figures 1A to 1F) or, alternatively, it can be supplied from a dedicated circuit within the 608 analog-to-digital converter. The ADC 608 output, adc_data, is transmitted to the digital signal processor and 118/130 system controller block (see Figure 1C). Although illustrated in Figure 1C as individual blocks 118 and 130, for ease of explanation, digital signal processor 118 and system controller 130 can be implemented in a single block 610. The activation signal, adc_en, the start signal , adc_start, and the reset signal, adc_rst_n are received from the digital signal processor and system controller 610 while the complete signal, adc_complete, is transmitted to it. The clock signal, adc_clk, can be received from a clock source external to the signal path, pd_rx_top, or from the 610 digital signal processor and system controller. It is important to note that the adc_clk signal and the clock system may be operating at different frequencies. It is also important to note that any number of different ADCs can be used according to at least one modality that has different interfaces and control signals, but that performs a similar function of providing a sampled digital representation of the output of the analog portion of the signal path. of the photosensor. The activation of photodetection, pd_en, and the gain of photodetection, pd_gain, are received from the digital signal processor and system controller 610.
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50/114 [0114] Figure 7 illustrates a block diagram of the digital conditioning logic 700 that can be used to reduce the value of the received ADC signal, adc_data, to a single bit value, pd_data. The digital conditioning logic 700 can include a digital register 702 to receive data, adc_data, from the pd_rx_top photodetection signal path to provide a value that is maintained in the adc_data_held signal. Digital register 702 is configured to accept a new value in the adc_data signal when the adc_complete signal is confirmed and to otherwise maintain the last accepted value when the adc_complete signal is received. In this way, the system can deactivate the path of the photodetection signal when the data is finalized to reduce the current consumption of the system. The value of maintained data can then be prorated, for example, by an integration and reset average or other averaging methods implemented in digital logic, in the threshold creation circuit 704 to produce one or more thresholds in the pd_th signal . The maintained data value can then be compared, through a compared 706, to one or more thresholds to produce a one-bit data value in the pd_data signal. It should be understood that the comparison operation can employ hysteresis or comparison to one or more thresholds to minimize noise in the output signal pd_data. The digital conditioning logic can additionally include a gain adjustment block pd_gain_adj 708 to adjust the gain of the filter stage with automatic gain and low pass 606 in the photodetection signal path, through the pd_gain signal, illustrated in Figure 6, according to the calculated limit values, and / or according to the data value maintained. It is important to note that in this example mode, six-bit words provide sufficient resolution across the dynamic range for blink detection, but reduce complexity. Figure 7 illustrates an alternative modality that includes providing
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51/114 a control signal pd_gain_sdi, for example, from the serial data interface that allows the automatic gain control determined by the gain adjustment block pd_gain_adj 708 to be ignored.
[0115] In an exemplary embodiment, the threshold generation circuit 704 includes a peak detector, a valley detector and a threshold calculation circuit. In this mode, the threshold values and gain control can be generated as follows. The peak detector and the valley detector are configured to receive the value maintained in the adc_data_held signal. The peak detector is additionally configured to provide an output value, pd_pk, which quickly tracks increases in the value of adc_data_held and drops slowly if the value of adc_data_held drops. The operation is analogous to that of a classic diode envelope detector, as is well known in the electrical art. The voucher detector is additionally configured to provide an output value, pd_vl, which quickly tracks reductions in the value of adc_data_held and slowly increases to a larger value if the value of adc_data_held increases. The operation of the valley detector is also analogous to a diode envelope detector, with the discharge resistor attached to a positive power supply voltage. The threshold calculation circuit is configured to receive the pd_pl and pd_vl values and is additionally configured to calculate a pd_th_mid midpoint threshold value, based on the average of the pd_pk and pd_vl values. The threshold creation circuit 704 provides the threshold value pd_th based on the midpoint threshold value pd_th_mid.
[0116] The threshold generation circuit 704 can be further adapted to update the values of the pd_pk and pd_vl levels in response to changes in the pd_gain value. If the value of pd_gain increases by one step, then the values of pd_pk and pd_vl are increased by a factor equal to the expected gain increase in the path of the photodetection signal. If the value of pd_gain decreases by one step, then the
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52/114 pd_pk and pd_val values are reduced by a factor equal to the expected gain reduction in the photodetection signal path. In this way, the states of the peak detector and the valley detectors, as maintained in the pd_pk and pd_vl values, respectively, and the pd_th threshold value as calculated from the pd_pk and pd_vl values, are updated to match changes in path gain. signal, thus avoiding discontinuities or other changes in state or value, resulting only from the intentional change in the gain of the photodetection signal path.
[0117] In an additional exemplary modality of the limit creation circuit 704, the limit calculation circuit can be additionally configured to calculate a pd_th_pk limit value based on a proportion or percentage of the pd_pk value. In at least one embodiment, pd_th_pk can be advantageously configured to be seven octaves of the pd_pk value, a calculation that can be implemented with an offset to the right by three simple bits and a subtraction, as is well known in the relevant art. The threshold calculation circuit can select the threshold value pd_th to be the lowest of pd_th_mid and pd_th_pk. In this way, the value of pd_th will never be equal to the value of pd_pk, even after long periods of constant incident light on the photodiode, which can result in the values of pd_pk and pd_vl being equal. It must be considered that the value of pd_th_pk guarantees detection of a blink after long intervals. The behavior of the limit generation circuit is further illustrated in Figures 11A to 11G, as discussed below.
[0118] Figure 8 illustrates a block diagram of the digital detection logic 800 that can be used to implement a digital blink detection algorithm, according to at least one exemplary modality. The digital detection logic 800 can include an 802 shift register adapted to receive data
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53/114 of the path of the pd_rx_top photodetection signal, Figure 6, or of the digital conditioning logic, Figure 7, as shown here in the pd_data signal, which has a value of one bit. The shift register 802 maintains a history of the sample values received, here in a 24-bit register. The digital detection logic 800 also includes a comparison block 804 adapted to receive the sample history and one or more models bl_tpl and masks bl_mask based on the state of operation (if necessary), and is configured to indicate a combination with one or more models and masks on one or more exit signs that can be postponed for later use. In at least one mode, the state of operation determines the set of bl_tpl models and bl_mask masks to be used by comparison block 804. In at least one set of bl_tpl models, there is at least one sleep model representative of the user who falls asleep. In an alternative exemplary mode, the digital detection logic 800 includes a comparison block, adapted to contain one or more sleep models and is configured to indicate a combination with one or more models and masks in one or more output signals that can maintained for later use. In such an alternative exemplifying modality, the lens does not have the states of operation asleep and awake.
[0119] The output of the comparison block 804 is locked using a flip-flop D 806. The digital detection logic 800 may additionally include a counter 808 or other logic to suppress successive comparisons that can be in the same sample history established in small displacements due to masking operations. In a preferred embodiment, the sample history is removed or reset after a positive match is found, thus requiring a new full match to be sampled before being able to identify a subset match 870170039233, from 06/08/2017, p. 58/437
54/114 hot. The digital detection logic 800 can also include state equipment or a similar control circuit to supply the control signals to the path of the photodetection signal and to the ADC. In some embodiments, the control signals can be generated by control state equipment that is separate from the digital detection logic 800. This control state equipment can be part of the 610 digital signal processor and system controller (see Figure 6).
[0120] Figure 9 illustrates a timing diagram of the control signals provided from a detection subsystem to an ADC 608 (Figure 6) used in a photodetection signal path. The permission and clock signals adc_en, adc_rst_n and adc_clk are activated at the beginning of a sample sequence and continue until the analog to digital conversion process is finished. In one embodiment, the ADC conversion process begins when a pulse is provided in the adc_start signal. The output value of the ADC is maintained in an adc_data signal and the termination of the process is indicated by the logic of the analog-to-digital converter in an adc_complete signal. Also shown in Figure 9 is the pd_gain signal that is used to adjust the gain of the amplifiers before the ADC. The signal is shown to be adjusted before the warm-up time to allow the slope of the analog circuit and signal levels to stabilize before conversion.
[0121] Figure 10 illustrates a digital system controller 1000 having a digital blink detection subsystem dig_blink 1002. The digital blink detection subsystem dig_blink 1002 can be controlled by dig_master 1004 master status equipment and can be adapted to receive clock signals from a clkgen 1006 clock generator external to the digital system controller 1000. The digital blink detection subsystem dig_blink 1002 can be
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55/114 adapted to provide control signals and receive signals from a photodetection subsystem, as described above. The digital blink detection subsystem dig_blink 1002 can include digital conditioning logic and digital detection logic, as described above, in addition to state equipment to control the sequence of operations in a blink detection algorithm. The digital blink detection subsystem dig_blink 1002 can be adapted to receive an activation signal from master state equipment 1004 and to provide a termination or termination indication and a blink detection indication back to master state equipment 1004.
[0122] In an exemplary modality alternative to the modality illustrated in Figure 10, a clock is connected to the clock generator 1006 (in Figure 10) to track the time since the lens started operating, and to provide a time signal to the data manager, in a mode in which the data manager records data regarding the beginning and end of the user's sleep so that when data is transmitted (or sent) from the lens to an external device using, for example, at least one electronic communication component, the external device is able to determine which time periods the user was asleep while wearing the lens, by reversing the time of day, based on the time stamp of the lens and the current time on the external device, when data is transmitted in comparison to the registered timestamps.
[0123] Figures 11A to 11G represent waveforms to illustrate the operation of the limit creation circuit and automatic gain control (Figure 7). Figure 11A illustrates an example of a photocurrent as a function of time, as it could be provided by a photodiode in response to different lighting levels. In the first portion of the
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56/114 graph, the lighting level and the resulting photocurrent are relatively low compared to the second portion of the graph. In both the first and second portions of the plot, it is noticed that a double blink reduces the light and the photocurrent. It is observed that the attenuation of light by the eyelid may not be one hundred (100) percent, but a lower value depending on the transmission properties of the eyelid for the wavelengths of light incident on the eye. Figure 11B illustrates the value of adc_data_held that is captured in response to the photocurrent waveform of Figure 11 A. For the sake of simplicity, the value of adc_data_held is illustrated as a continuous analog signal and not a series of distinct digital samples. It must be considered that the digital sample values will correspond to the level illustrated in Figure 11B at the corresponding sampling times. The dashed lines on the upper and lower sides of the graph indicate the maximum and minimum values of the adc_data and adc_data_held signals. The range of values between the minimum and maximum is also known as the dynamic range of the adc_data signal. As discussed below, the gain of the photodetection signal path is different (lower) in the second portion of the graph. In general, the value of adc_data_held is directly proportional to the photocurrent, and the gain changes affect only the proportionality ratio or constant. Figure 11C illustrates the values of pd_pk, pd_vl and pd_th_mid calculated in response to the value of adc_data_held by the threshold generation circuit. Figure 11D illustrates the values of pd_pk, pd_vl and pd_th_pk calculated in response to the value of adc_data_held in some modalities of the threshold generation circuit. It is observed that the pd_th_pk value is always some proportion of the pd_pk value. Figure 11E illustrates the value of adc_data_held with the values of pd_th_mid and pd_th_pk. It is observed that during long periods of time where the adc_data_held value is relatively constant, the value
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57/114 pd_th_mid becomes equal to the adc_data_held value as the pd_vl value falls at the same level. The value of pd_th_pk always remains somewhat below the value of adc_data_held. Also shown in Figure 11E is the selection of pd_th, where the value of pd_th is selected to be the lowest of pd_th_pk and pd_th_mid. In this way, the threshold is always established at some distance from the pd_pk value, avoiding false transitions in pd_data due to noise in the photocurrent and adc_data_held signals. Figure 11F illustrates the value of pd_data generated by comparing the value of adc_data_held with the value of pd_th. Note that the pd_data signal is a two-value signal that is low when a blink is occurring. Figure 11G illustrates a value of tia_gain versus time for these waveform examples. The value of tia_gain is set lower when the pd_th starts to cross a high threshold shown as agc_pk_th in Figure 11E. It will be recognized that a similar behavior occurs to increase the tia_gain when pd_th starts to fall below a low threshold. Looking again at the second portion of each of Figures 11A to 11E, the effect of the minor tia_gain is clear. In particular, note that the adc_data_held value is kept close to the middle of the dynamic range of the adc_data and adc_data_held signals. Additionally, it is important to note that the pd_pk and pd_vl values are updated according to the gain change, as described above, so that discontinuities are avoided in the peak and valley detector states and values due only to changes in the path gain of the photodetection signal.
[0124] Additional exemplary blink detection modes may allow for greater variation in the duration and spacing of the blink sequence, for example by timing the start of a second blink based on the measured end time of a first blink, instead of using a fixed model, or by ampliPetition 870170039233, from 06/08/2017, p. 62/437
58/114 action of ignored mask intervals (values 0).
[0125] Figure 12 illustrates light blocking and light passing characteristics in an integrated circuit matrix 1200. The integrated circuit matrix 1200 includes a light passage region 1202, a light blocking region 1204, connection blocks 1206, passivation openings 1208 and openings of the light blocking layer 1210. The light passage region 1202 is located above photosensors (not shown), for example, a set of photodiodes implemented in the semiconductor process. In at least one modality, the region of light passage 1202 allows the maximum possible light to reach the photosensors, thus maximizing their sensitivity. This can be done by removing polysilicon, metal, oxide, nitride, polyimide, and other layers above the photoreceptors, as allowed in the semiconductor process used for manufacturing or in further processing. The light passage area 1202 can also receive other special processing to optimize the detection of light, for example, an anti-reflective coating, filter and / or diffuser. The light blocking region 1204 can cover other circuits in the matrix that do not require exposure to light. The performance of the other circuit can be degraded by photocurrents, for example, shifting impulse voltages and oscillator frequencies in the ultra-low current circuits necessary for incorporation into contact lenses, as previously mentioned. The light blocking region 1204 is formed with a thin, opaque and reflective material, for example aluminum or copper, already used in the processing and post-processing of a semiconductor wafer. If implemented with metal, the material that forms the light blocking region 1204 must be isolated from the circuits below and connection areas 1206 to avoid short circuit conditions. Such isolation can be provided by the passivation already present in the matrix as part of the passivation of pastiPetição 870170039233, of 06/08/2017, p. 63/437
59/114 normal sheet, for example, oxide, nitride, and / or polyimide, or with another dielectric added during further processing. The masking allows openings in the light blocking layer 1210, so that the conductive light blocking metal does not overlap the connection areas in the matrix. The light blocking region 1204 is covered with additional dielectric or passivation to protect the matrix and prevent short circuits during fixing the matrix. This final passivation has passivation openings 1208 to allow connection to connection blocks 1206.
[0126] In an alternative exemplifying modality in which the contact lens includes toning features, the region through which the 1202 light passes is at least partially superimposed on the region of the contact lens capable of being toned. Where photosensors are present in the toning region and in the non-toning regions of the contact lens, this makes it possible to determine the amount of light being blocked by the toning. In an additional exemplary modality, the entire region through which the light passes through 1202 is present in the toning region.
[0127] Figure 13 illustrates a contact lens with an electronic insertion element having a blink detector system. The contact lens 1300 (you need to change this in the drawing) includes a soft plastic portion 1302 that provides an electronic insertion element 1304. This insertion element 1304 includes a lens 1306 that is activated by the electronic circuit, for example, focusing close or far depending on activation. Integrated circuit 1308 rests on insertion element 1304 and connects to batteries 1310, lens 1306, and other components as needed for the system. In at least one embodiment, integrated circuit 1308 includes a photosensor 1312 and associated circuits of the photosensor signal path. Photosensor 1312 faces outward through the
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60/114 lens insert element and away from the eye, and is then able to receive ambient light. Photosensor 1312 can be implemented on integrated circuit 1308 (as shown) for example as a single photodiode or set of photodiodes. Photosensor 1312 can also be implemented as a separate device mounted on insertion element 1304 and connected with electrical connections 1314. When the eyelid closes, lens insertion element 1304, including photodetector 1312 is covered, thereby reducing the level of light incident on the photodetector 1312. The photodetector 1312 is capable of measuring ambient light to determine whether the user is blinking or not. Based on this disclosure, one skilled in the art should note that photodetector 1312 can be replaced or augmented by other sensors discussed in this disclosure.
[0128] It must be considered that blink detection and / or sleep detection can be implemented in digital logic or in software running on a microcontroller. The algorithm or microcontroller logic can be implemented in a single application-specific integrated circuit (ASIC), with a photodetection signal path circuit and a system controller, or it can be partitioned over more than one integrated circuit .
[0129] According to another example, an energized or electronic ophthalmic lens may incorporate an eyelid position sensor. Eyelids are known to protect the globe in a number of ways, including the blink reflex and tear dispersion action. The blinking reflex of the eyelids prevents trauma to the globe by quickly closing in the face of the perception of a threat to the eye. The blink also disperses tears on the globe's surface to keep it moist and rinse off bacteria and other foreign matter. But the movement of the eyelids can also indicate other actions or functions in question, in addition to being
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61/114 used to alert an individual (or user) using an electronic ophthalmic lens that an alarm has been activated.
[0130] Now with reference to Figure 14A, an eyelid position sensor system in an eye 1400 is illustrated. The system is incorporated into a 1402 contact lens. The upper and lower eyelids are shown, with the upper eyelid having possible locations 1401, 1403 and 1405 in ascending closing order. The lower eyelid is also illustrated with levels of closure that correspond to the upper eyelid; namely, locations 1407, 1409 and 1405. When the eyelids are closed, they occupy the same position; namely, 1405. The contact lens 1402 according to this exemplary embodiment includes an array of sensors 1404. This array of sensors 1404 includes one or more photosensors. In this modality, the array of sensors 1404 includes twelve (12) photosensors 1406a to 14061. With the upper eyelid in position 1401 and the lower eyelid in position 1407, all photosensors 1406a to 1406 I are exposed and receive ambient light, thus creating , a photocurrent that can be detected by an electronic circuit described in this document. With the eyelids partially closed at positions 1403 and 1409, the upper and lower photosensors 1406a and 1406b are covered, receive less light than the other photosensors 1406c to 14061, and emit a correspondingly lower current that can be detected by the electronic circuit. With the lids fully closed in position 1405, all sensors 1406a to 1406 I are covered with a corresponding reduction in current. This system can be used to detect the position of the eyelid by sampling each photosensor in the sensor matrix and using the photocurrent output depending on the position of the sensor to determine the position of the eyelid, for example, if the upper and lower eyelids do not open completely after blinking indicating possible start of
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62/114 sleep or fatigue. It will be recognized that photosensors should be placed in suitable locations on the contact lens, for example, providing sufficient sample locations to reliably determine the position of the eyelid while not obstructing the clear optical zone (above, the area occupied by an enlarged pupil ). This system can also be used to detect blinks, by sampling the sensors in the usual way and by comparing measurements over time. In an alternative exemplary embodiment, the photosensors 1406a'-1406l 'of an array of sensors 1404' form an arcuate pattern around the pupil at the same time that they are vertically spaced apart as illustrated, for example, in Figure 14B. In any of the illustrated modalities, the person skilled in the art must understand that a number other than 12 can be used in the array of sensors. Examples additionally include a number in a range of 3 to 15 (including the end points in at least one mode) in more particularly, a number in a range of 4 to 8 (including the end points in at least one mode).
[0131] Figures 15A and 15B illustrate an electronic system 1500 in which eyelid position photosensors, as shown above, are used to trigger activity on a 1502 contact lens or, more specifically, on an energized or electronic ophthalmic lens. Figure 15A shows the electronic system 1500 on lens 1502 and Figure 15B is an exploded view of system 1500. Light 1501 is incident on one or more photosensors 1504, as previously described in relation to Figures 14A and 14B. These 1504 photosensors can be deployed with photodiodes, cadmium sulfide (CdS) sensors, or other technologies suitable for converting ambient light into current. Depending on the choice of 1504 photosensors, 1506 amplifiers, or another suitable circuit, may be required to condition input signals for use
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63/114 for subsequent or downstream circuits. A 1508 multiplexer allows a single 1510 analog-to-digital converter (or ADC) to accept inputs from multiple photosensors 1504. The multiplexer 1508 can be placed immediately after photosensors 1504, before amplifiers 1506, or may not be used depending on consumption considerations current, matrix size and model complexity. Since multiple 1504 photosensors are needed at various positions in the eye to detect the position of the eyelid, sharing downstream processing components (for example, amplifiers, an analog-to-digital converter and digital signal system controllers) can significantly reduce the size required for electronic circuits. The 1506 amplifiers create output proportional to the input, with gain, and can function as transimpedance amplifiers that convert input current into output voltage. The 1506 amplifiers can amplify a signal to a level usable by the rest of the system, as giving the signal enough voltage and energy to be captured by the ADC 1510. For example, the 1506 amplifiers may be needed to target subsequent blocks, since the output of the 1504 photosensors can be quite small and can be used in low light environments. The 1506 amplifiers can also be deployed as variable gain amplifiers, the gain of which can be adjusted by a 1512 system controller to maximize the dynamic range of the 1500 system. In addition to the gain provision, the 1506 amplifiers can include another analog signal conditioning circuit, such as filtration and another circuit suitable for the outputs of photosensor 1504 and amplifier 1506. Amplifiers 1506 can be any device suitable for amplifying and conditioning the signal output by photosensor 1504. For example, 1504 amplifiers can simply be a single
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64/114 operational amplifier, or a more complicated circuit that includes one or more operational amplifiers.
[0132] As shown above, photosensors 1504 and amplifiers 1506 are configured to detect incident light 1501 at various positions in the eye and convert the input current into a digital signal usable essentially by the 1512 system controller. In at least one example mode , the system controller 1512 is pre-programmed to take samples of each photosensor 1504 in the eye, in order to detect the position of the eyelid and provide an output signal suitable for an alert mechanism 1514. The system controller 1512 also includes a associated memory. The 1512 system controller can combine recent samples from photosensors 1504 to pre-programmed patterns correlated to open and half-closed eyelid positions. The 1500 system may need to differentiate between changes in eyelid position, normal changes in ambient light, shadows and other phenomena. Differentiation can be done through appropriate selection of the sampling frequency, amplifier gain and other system parameters, optimization of sensor placement on the contact lens, determination of eyelid position patterns, recording of ambient light, comparing each photosensor to adjacent photosensors and other photosensors, and other techniques to discern the position of the eyelid unambiguously.
[0133] In at least one example mode, the ADC 1510 can be used to convert a continuous analog signal output from amplifiers 1506, through the multiplexer and into a sampled digital signal suitable for further signal processing. For example, the ADC 1510 can convert an analog signal output from the 1506 amplifiers into a digital signal that can be used by subsequent or downstream circuits, such as a system 870170039233, from 06/08/2017, p. 69/437
65/114 digital signal processing system or microprocessor 1516. A digital signal processing system or digital signal processor 1516 can be used to process digital signal, including one or more among filtering, processing, detecting and otherwise manipulate / process the sampled data to allow detection of incident light for later use. The 1516 digital signal processor can be pre-programmed with various position patterns and / or eyelid closure. The digital signal processor 1516 also includes associated memory in at least one mode. The 1516 digital signal processor can be deployed using analog circuit, digital circuit, software and / or, preferably, a combination thereof. The ADC 1510 together with amplifiers 1506 and the associated digital signal processor 1516 are activated at an appropriate rate in accordance with the sampling rate previously described, for example, every hundred (100) ms.
[0134] A 1518 power supply provides power to numerous components, including the 1500 eyelid position sensor system. The 1518 power supply can also be used to supply power to other contact lens components. The power can be supplied by a battery, a power collector, or other suitable means, as previously discussed. Essentially, any type of 1518 power source can be used to provide reliable power for all other components in the system. An eyelid position sensor matrix pattern, processed from analog to digital, can enable activation of the 1512 system controller or a portion of the 1512 system controller. In addition, the 1512 system controller can control other aspects of a lens energized contact, depending on the input from the 1508 digital signal system controller, such as the activation of the 1514 alert mechanism.
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66/114 [0135] Now with reference to Figure 16, an output characteristic for three photosensors positioned in three different vertical positions on the contact lens is illustrated. The output characteristics can represent the current proportional to the incident light in each photosensor or they can represent a downstream signal, for example, digital sampled data values as a function of time at the ADC output (element 1510 in Figure 15B). The total incident light 1602 increases, remains stationary, and then decreases, for example, when walking from a dark environment to a bright corridor, and then back to the dark environment. All three photosensors 1604, 1606 and 1606 would emit a signal similar to that of ambient light if the eyelid remained open, illustrated by dotted lines 1601 and 1603 for photosensors 1604 and 1608. In addition to changing the level of ambient lighting 1602, closing of the eyelids is indicated by position 1610, different from that of the open eyelid positions 1612 and 1614. When the eyelid partially closes, the upper photosensor 1604 becomes covered by the upper eyelid and emits a correspondingly lower level due to the obstruction of the photosensor by the photosensor. eyelid. Despite the increasing ambient light 1602, photosensor 1604 receives less light and emits a lower signal due to the partially closed eyelid. A similar response is observed with the 1608 photosensor that becomes covered. The 1606 medium sensor is not covered during semi-shutdown and therefore continues to see the lighting level increase, with a corresponding increase in the output level. Although this example illustrates a particular case, it should be evident that several settings of sensor position and eyelid movement could be detected.
[0136] Figures 17A and 17B illustrate an alternative 1700 detection system incorporated into a 1702 contact lens. Figure 17A illustrates the 1700 system in lens 1702, and Figure 17B illustrates a view
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67/114 exploded from the 1700 system. In this example mode, 1704 capacitive touch sensors are used instead of photosensors. Capacitive touch sensors are common in the electronics industry, for example, on touch screens. The basic principle is that a capacitive touch sensor (or variable capacitor) 1704 is physically implanted so that the capacitance varies with proximity or touch, for example, by implanting a grid covered by a dielectric. The 1706 sensor conditioners create an output signal proportional to the capacitance, for example, by measuring the change in an oscillator that has the variable capacitor or by capturing the ratio between the variable capacitor and the fixed capacitor with an AC signal of fixed frequency. The output of the 1706 sensor conditioners can be combined with a 1708 multiplexer to reduce the downstream circuit. In this exemplary modality, the necessary signal conditioning circuit, as described above in relation to Figure 15B, is omitted for the sake of simplicity. A 1710 system controller receives inputs from capacitance sensor conditioner 1706 through multiplexer 1708, for example, by activating each sensor in order and recording the values. It can then compare measured values to preprogrammed patterns and historical samples to determine the position of the eyelid. It can then activate a function in a 1712 alert mechanism, for example, cause a variable focus lens to change to a closer focal length. Capacitive touch sensors 1704 can be arranged in a physical pattern similar to that previously described for photodetectors, but in at least one modality they would be optimized to detect changes in capacitance with the position of the eyelid. The sensors, and for the matter, the entire electronic system, would be encapsulated and isolated from the saline environment of the contact lens. Since the eyelid covers a sensor
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1704, the change in capacitance would be detected instead of the change in ambient light previously described. Figure 17B also illustrates the inclusion of a 1714 power source in at least one modality, which could take a variety of forms, as previously discussed.
[0137] It is important to note that the ADC and the digital signal processing circuit can be used according to the capacitive touch sensors, if necessary, as illustrated with respect to the photosensors in Figure 15B. In an alternative exemplary mode, capacitive touch sensors are any pressure sensor. In another example, there is a combination of photosensors and pressure sensors on the lens.
[0138] Figures 18A to 18D illustrate an alternative exemplary embodiment where the eyelid position sensor system is a sensor that has a strip 1808, 1808a, 1808b that covers a plurality of vertical points along the 1802 contact lens that operates in in conjunction with circuit 1800. An example of a sensor that can have a strip configuration is a capacitance sensor. Figure 18A illustrates an example where strip 1808 is substantially straight on contact lens 1802. Although strip 1808 is shown to be oriented parallel to a line that bisects contact lens 1802, it may have an inclined orientation with respect to the line bisection or have an arched shape. Figure 18B illustrates an example where strip 1808a traverses a serpentine passage along contact lens 1802. In the embodiment illustrated in Figure 18C, the serpentine configuration of strip 1808b will increase the change in capacitance detected by circuit 1800 as the eyelids approach a closed state. The level of change in capacitance will inform the amount of closure of the eyelid. Another example of a sensor that can have a strip configuration is a pressure transducer
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69/114 piezoelectric with a diaphragm and a base having a strip configuration. As the eyelids close, additional pressure will be applied by the eyelids against the piezoelectric pressure transducer, thus allowing the level of eyelid closure to be determined. Continuous detection along the vertical axis provides improved granularity over a plurality of sensors, thereby providing improved measurement of the eyelid location. Figure 18D illustrates an electrical circuit that can be used in conjunction with strip sensors 1808, 1808a, 1808b that includes a system controller 1810, an alert mechanism 1812 and a power source 1814, as discussed above. In another alternative example, multiple tapes are present. An advantage of a serpentine and / or angled strip configuration is that the position of the eyelid can still be detected even if the contact lens is oriented incorrectly in the user's eye.
[0139] The activities of the digital signal processing block and the system controller (1516 and 1512 in Figure 15B, respectively, the system controller 1710 in Figure 17B and the system controller 1810 in Figure 18D) depend on the sensor inputs available, the environment and user reactions. Entry, reaction and decision thresholds can be determined from one or more ophthalmic research, pre-programming, training and adaptive / learning algorithms. For example, the general characteristics of eyelid movement can be well documented in the literature, applicable to a wide population of users, and pre-programmed in the system controller. However, an individual's deviations from the expected general response and / or changes in the blink frequency can be recorded in a training session or part of an adaptive / learning algorithm that continues to refine the response in the
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70/114 operation of the electronic ophthalmic device. In a modality, the user can train the device by activating a remote fob control, which communicates with the device, when the user wants close focus. A learning algorithm on the device can then reference the sensor inputs in memory before and after the fob remote signal to refine the internal decision algorithms. This training period could last for one day, after which the device would operate autonomously with only the sensor inputs and without the need for the remote fob control. [0140] In an alternative exemplary modality, the system additionally includes an eye movement sensor system. In another example, if the system controller receives from the eye movement sensor and system, readings that the user is in the prone position and, from the eyelid position sensor system, readings that the eyelids are closed, then the type of alarm can be adjusted to reflect that the user is sleeping. In another example, the alarm is initiated at a low intensity, which grows over a period of time to provide a smoother wake for the user. In an alternative example mode, the alarm provided is a scaled alarm.
[0141] Figures 19A and 19B illustrate an exemplary 1900 eye movement sensor system for detecting eye movement. The 1902 sensor detects the movement and / or position of the pupil or, more generally, of the eye. The 1902 sensor can be implemented as a multiaxial accelerometer on a 1901 contact lens. With the 1901 contact lens being attached to the eye and, in general, moving with the eye, an accelerometer on the 1901 contact lens can track the movement of the eye. It is important to note that any suitable device can be used as the 1902 sensor, and more than
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71/114 a single 1902 sensor can be used. The 1902 sensor output is captured, sampled, and conditioned by the 1904 signal processor. The 1904 signal processor can include several devices including an amplifier, a transimpedance amplifier, an analog-to-digital converter, a filter, a digital signal processor , and related circuits to receive data from the 1902 sensor and generate an output in a format suitable for the other components of the 1900 eye motion sensor system. The 1904 signal processor can be implemented using an analog circuit, a digital circuit , software, and / or a combination thereof. In at least one example embodiment, the 1904 signal processor and the 1902 sensor are manufactured in the same integrated circuit matrix. The sensor circuit for capturing and conditioning an accelerometer is different from the circuit for a muscle activity sensor or optical pupil tracker. The output of the 1904 signal processor, in at least one exemplary mode, is a sampled digital current and can include an absolute or relative position, movement, gaze detected in agreement with convergence, or other data. The 1906 system controller receives inputs from the 1904 signal processor and uses this information, in conjunction with other inputs, to determine information regarding the position of the eye. The 1906 system controller can trigger the activity of both the 1902 sensor and the 1904 signal processor, while receiving an output from them. [0142] The 1906 system controller uses input data from the 1904 signal processor and / or the 1910 transceiver to decide whether the user is lying down (or in the prone position), based on the orientation of the 1902 sensor, based on the orientation of the X, Y and Z axes when no eye movement is detected. If the axes are as shown in Figure 19C, then when the accelerometer detects stable acceleration on the X axis in any direction or on the Z axis in
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72/114 any direction, the user's head has a vertical orientation. When the accelerometer detects steady acceleration on the Y axis in the negative direction, then the user's head is vertical. When the accelerometer detects stable acceleration on the Y and Z axes with or without stable acceleration on the X axis, then the user's head is tilted forward.
[0143] In another example, the 1906 system controller uses data from the 1902 sensor in conjunction with the data from a timing circuit to calculate acceleration-deceleration forces for the user. When the acceleration exceeds a concussion threshold, which is an example of a problem model, or, in an alternative mode, when the calculated force exceeds a concussion force, the system controller triggers an alert with the 1908 alert mechanism and / or initiate a concussion test protocol. In another mode, the 1906 system controller receives an approximate user weight before calculating the acceleration-deceleration force. In yet another embodiment, the 1906 system controller adds the calculated acceleration-deceleration force to a cumulative force value. When the cumulative force value exceeds a repetitive concussion threshold, which in at least one mode is a constant value, while in another mode it is a variable number of adjustment over time. In at least one embodiment where a storage box is used, the cumulative force value is loaded into the next pair of contact lenses to provide long-term force tracking. [0144] Figure 19B illustrates an optional 1910 transceiver, briefly described above, that receives and / or transmits communications through the 1912 antenna. This communication can come from an adjacent contact lens, spectacle lenses, or other devices. The 1910 transceiver can be configured for bidirectional communication with conPetition 870170039233, from 06/08/2017, pg. 77/437
73/114 1906 system controller. The 1910 transceiver can contain filtration, amplification, detection, and processing circuits, as is common with transceivers. The specific details of the 1910 transceiver are tailor-made for an electronic or powered contact lens, for example the communication can be at a frequency, amplitude, and shape suitable for reliable communication between the eyes, low power consumption, and to achieve regulatory requirements. The 1910 transceiver and the 1912 antenna can work in the radio frequency (RF) band, such as 2.4 GHz, or they can use light for communication. The information received from the 1910 transceiver is inserted into the 1906 system controller, for example, information from an adjacent lens that indicates orientation. The 1906 system controller can also transmit data, for example, from the 1908 alert mechanism to the 1910 transceiver, which then transmits the data over the communication link via the 1912 antenna.
[0145] The 1906 system controller can be implemented as a state machine, in a field programmable port array, in a microcontroller, or in any other suitable device. The power for the 1900 system and the components described here is provided by a 1914 power source.
[0146] In at least one exemplary embodiment, the eye movement sensor system 1900 is incorporated and / or otherwise encapsulated and isolated from the saline environment of the 1901 contact lens.
[0147] Figure 20 illustrates a system through which the convergence or divergence of two pupils and / or the eye can be detected and communicated between a pair of 2000 contact lenses. 2002 pupils are illustrated converged to view a close object . The 2004 pupil position and convergence detection systems incorporated in the 2000 contact lenses that are positioned
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74/114 in eyes 2006 track the position of pupils 2002 and / or contact lenses 2000, for example, with photodetectors aimed at the iris to observe pupils 2002 or with accelerometers to track eye movement 2006 and, consequently, of pupils 2002. For the purposes of this disclosure, the term facing the iris means facing towards the user's eye, and in another mode the term facing the iris includes having the component present on the side of the contact lens that comes in contact with the user's eye. Pupil 2004 position and convergence detection systems can include several components that form a more complex system, for example, a 3-axis accelerometer, a set of signal conditioning circuits, a controller, a memory, a power supply and a transceiver, as is subsequently described in detail. The 2001 communication channel between the two 2000 contact lenses allows the 2004 pupil position and convergence detection systems to be synchronized at the pupil position. Communication can also take place with an external device, such as glasses or a smartphone. Communication between 2000 contact lenses is important to detect convergence. For example, without knowing the position of both pupils 2002, simply looking down and to the left can be detected as convergence by the right eye, since pupil 2002 has a similar movement for both actions. However, if the right pupil is detected moving downwards and to the left, while the left eye pupil is detected moving downwards and to the right, a convergence can be constructed. The communication between the two contact lenses 2000 can take the form of absolute or relative position, or it can simply be a sign of suspicious convergence if the eye moves in the expected direction of convergence. In this case, if a given contact lens detects conversion itself, 870170039233, from 06/08/2017, p. 79/437
75/114 gence and receives an indication of convergence from the adjacent contact lens, it can activate a change in the stage, for example, by passing a contact lens equipped with a variable focus or variable power optical device to the state of short distance to assist in reading. Other useful information to determine the desire to settle (close focus), such as the position of the eyelid and the activity of the ciliary muscle, can also be transmitted along the 2001 communication channel if the contact lenses are equipped for the same. It should be understood that communication along the 2001 channel could include other signals perceived, detected, or determined by each of the 2006 lenses and used for a variety of purposes, including vision correction, vision enhancement, entertainment and innovation.
[0148] In at least one exemplary mode, the system illustrated in Figure 19B has a 1902 sensor which is a sensor that detects the movement and / or position of the pupil or, more generally, of the eye. The 1902 sensor can be implemented as a multiaxial accelerometer on a 1901 contact lens. With the 1901 contact lens being attached to the eye and, in general, moving with the eye, an accelerometer on the 1901 contact lens can track the movement of the eye. The 1902 sensor can also be implemented as a camera or sensor facing the iris, which detects changes in images, patterns, or contrast to track eye movement. Alternatively, the 1902 sensor may comprise neuromuscular sensors to detect nerve and / or muscle activities that move the eye in the orbit. There are six muscles attached to each eyeball that provide each eye with a full range of motion, and each muscle has its own unique action or actions. These six muscles are innervated by one of the three cranial nerves (CN). The six extraocular muscles are the medial rectum which is innervated or controlled by CN3
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76/114 (oculomotor), the inferior rectus muscle also innervated by CN3, the lateral rectum which is innervated or controlled by CN6 (abducent), the superior rectum which is innervated or controlled by CN3, the superior oblique which is innervated or controlled by CN4 (trochlear) and the inferior oblique that is innervated or controlled by CN3. It is important to note that any suitable device can be used as the 1902 sensor, and more than one single 1902 sensor can be used. The 1902 sensor output is captured, sampled, and conditioned by the 1904 signal processor. In at least one example mode, the 1906 system controller receives inputs from the 1904 signal processor and uses this information, in conjunction with other inputs, to control the 1901. electronic contact lens. A 1910 transceiver receives and / or transmits communication through the 1902 antenna. This communication can come from an adjacent contact lens, eyeglass lenses, or other devices. Information received from the 1910 transceiver is inserted into the 1906 system controller, for example, information from an adjacent lens that indicates convergence or divergence. The 1906 system controller uses the input data from the 1904 signal processor and / or the 1910 transceiver to determine the look direction. The 1906 system controller can also transmit data to the 1910 transceiver, which then transmits the data over the communication link via the 1912 antenna. In at least one example, the 1900 pupil position and convergence detection system is incorporated and / or otherwise encapsulated and isolated from the saline environment of the 1901 contact lens. [0149] Figure 21 illustrates an example of correlation between convergence 2100 and focal length states 2102, 2104 and 2106, as is commonly documented in the literature ophthalmic. When in the distant focus state 2102 and 2106, the degree of convergence is low. When in the state of near focus 2104, the degree of convergence is
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77/114 high. A 2108 limit can be adjusted in the system controller (for example, element 1906 in Figure 19) to change the state of the electronic ophthalmic lens, for example, by focusing on an optical variable with additional power when the limit is passed positively, and then focusing on variable optics without any additional power when the limit is passed negatively.
[0150] Eye tracking is the process that determines where one or both of an individual's eyes are looking, the point of view, or the movement of an eye in relation to the head. A direction of the individual's gaze is determined by the orientation of the head and the orientation of the eyes. More specifically, the orientation of the individual's head determines the general direction of the look, while the orientation of the individual's eyes determines the exact direction of the look which, in turn, is limited by the orientation of the head. Information about where an individual is looking provides the ability to determine the individual's focus of attention and that information.
[0151] It is important to note that the eye tracking according to the present invention can be adjusted for monitoring thick or thin tracking.
[0152] Figures 22A and 22B illustrate a pair of eyes 2201 that observe an object (not shown) to the user's right. Figure 22A illustrates a front view of eyes 2201, while Figure 22B illustrates a top view of eyes 2201. The position on the right is used for illustrative purposes, but it will be understood that the object under observation could be anywhere visible in a space three-dimensional with the corresponding changes in the look. As illustrated, by exaggeration, both pupils 2203 are turned to the right. The lines 2205 drawn between pupils 2203 and the object under observation are almost parallel, since the object is illustrated as being much further from the eyes 2201 than the distance 870170039233, from 06/08/2017, p. 82/437
78/114 between the eyes 2201. The angle 2207 is less than ninety (90) degrees, while the angle 2209 is greater than ninety (90) degrees. These angles are in contrast to the previous angles, where the angles were both ninety (90) degrees when looking at a distant object directly in front, or were both less than ninety degrees when looking at an object close directly to the front. As illustrated in two dimensions, the angle can be used to determine the position of the look or, more generally, samples of eye movement can be used to determine an absolute and relative position and movement of the look.
[0153] Figure 23 illustrates the geometric systems associated with various directions of looking. Figure 23 is a top view. Eyes 2301 and 2303 are shown looking at several targets identified as A, B, C, D and E. One line connects each eye 2301 and 2303 to each target. A triangle is formed by each of the two lines connecting eyes 2301 and 2303 to a given target, in addition to a line connecting both eyes 2301 and 2303. As can be seen in the illustration, the angles between the direction of the eye in each eye 2301 and 2303 and the line between the two eyes 2301 and 2303 varies for each target. These angles can be measured by the sensor system, determined from indirect sensor measurements, or they can be shown for illustrative purposes only. Although shown in a two-dimensional space for the sake of simplicity of illustration, it must be apparent that the look occurs in a three-dimensional space, with the corresponding addition of an additional axis. Targets A and B are shown relatively close to eyes 2301 and 2303, for example, to be read with close focus accommodation. Target A is to the right of both eyes 2301 and 2303, so both eyes 2301 and 2303 are to the right. Measuring the angle formed counterclockwise between the horizontal axis, illustrated collinear with the coPetition line 870170039233, from 06/08/2017, p. 83/437
79/114 nectifying the two eyes 2301 and 2303, and the direction of the look, both angles are acute for target A. Now with reference to target B, eyes 2301 and 2303 are converged on a target in front of and between both eyes 2301 and 2303. For this reason, the angle, previously defined as counterclockwise from the horizontal axis and the direction of the gaze, is obtuse for the right eye 2303 and acute for the left eye 2301. A suitable sensor system will differentiate the difference position between targets A and B with adequate accuracy for the relationship application. Target C is shown at an intermediate distance for the special case of the right eye 2303 having the same direction of look and angle as on target B. The direction of the look varies between targets B and C allowing a system to determine the direction of the gaze use inputs from both eyes 2301 and 2303 to determine the direction of the gaze. In addition, a case could be illustrated where another target F (not shown) is above target B in three-dimensional space. In such an example, projected in the two-dimensional illustration shown in Figure 23, the angles from the horizontal axis would be identical to those illustrated for target B. However, the normal angles to the page extending in three-dimensional space would not be the same between the targets. Finally, targets D and E are shown as distant objectives. These examples illustrate that, as the object under observation is further away, the angle difference in eyes 2301 and 2303 between distant points becomes smaller. A system suitable for detecting the direction of the gaze would have sufficient accuracy to differentiate between small and distant objects.
[0154] The direction of the gaze can be determined by several suitable devices, for example, with photodetectors aimed at the iris to observe the pupils or with accelerometers to track the movement of the eyes. Neuromuscular sensors can also be used. When monitoring the six extraocular muscles that controlPetition 870170039233, of 06/08/2017, p. 84/437
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The movement of the eye went, the precise direction of the look can be determined. A memory element to store a previous position and / or acceleration may be required in addition to a position computing system, taking into account current and previous sensor inputs. In addition, the system illustrated in Figures 19A and 19B is equally applicable to the eye and tracking system of the present invention. In at least one example, the system controller is programmed to take into account the geometries of looking in three-dimensional space.
[0155] It is known in the optometry technique that the eyes do not remain completely stable when looking at a stationary object. Instead, the eyes move quickly back and forth. A system suitable for detecting the position of the eye would include the filtration and / or compensation necessary to take visual physiology into account. For example, such a system could include a low-pass filter or an algorithm specially tuned to the natural behaviors of the user's eye.
[0156] The activities of the processing block and the system controller for capturing the sampling signal (1904 and 1906 in Figure 19B, respectively) depend on the available sensor inputs, the environment, and the user reactions. Entry, reaction and decision thresholds can be determined from one or more ophthalmic research, pre-programming, training and adaptive / learning algorithms. For example, the general characteristics of eye movement can be well documented in the literature, applicable to a wide population of users, and pre-programmed in the system controller. However, an individual's deviations from the expected general response can be recorded in a training session or part of an adaptive / learning algorithm that continues to refine the response in the operation of the electronic ophthalmic device. Petition 870170039233, 06/06/2017, p. . 85/437
81/114 co. In at least one example mode, the user can train the device by activating a remote control, which communicates with the device, when the user wants close focus. A learning algorithm on the device can then reference the sensor inputs in memory before and after the fob remote signal to refine the internal decision algorithms. This training period could last a day or any other suitable period of time, after which the device would operate autonomously with only the sensor inputs and without the need for the remote fob control.
[0157] In at least one example, the energized or electronic ophthalmic lens includes a pupil diameter sensor facing the iris. The size and changes of the pupils; that is, dilation and contraction can be used to control one or more aspects of the energized or electronic contact lens. In other words, signals emitted from the pupil sensor can be inserted into a system controller which, in turn, performs a specific action based on the input and sends a signal to an alert mechanism.
[0158] The iris is the partition between the anterior and posterior chambers of the eye. The iris is connected to the ciliary muscle as well as the lens. The iris is formed by two muscles that regulate its central passage, commonly called the pupil. Similar to a camera shutter, the pupil, through the actions of the two muscles, controls the amount of light that enters the eye. The size of the pupil varies with age, the color of the iris, and the refractive error, if any; however, several other factors can affect the size of the pupils at any given time. The iris constantly reacts to light and emotion, so any sensors must take these normal fluctuations into account, as explained in more detail below, together
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82/114 with other reasons that can change the size of the pupil. In addition, pupil size can be a good diagnostic tool for certain conditions, including damage to the cranial nerve.
[0159] Pupils can become dilated with the use of certain agents, for example, a cycloplegic drug, such as atropine. The pupils can become dilated as a result of paralysis of the third cranial nerve. The pupil can be dilated and fixed to a direct light stimulus and a consensual light stimulus after an acute narrow-angle glaucoma. Alternatively, pupils may contract with the use of glaucoma medications, such as pilocarpine. Other drugs, for example, morphine, cause pupils to contract. In addition, certain conditions, for example, iritis, interruption of the sympathetic trajectories of the eye and irritating corneal lesions, can also cause pupil contraction. Hippus is a spasmodic, rhythmic, but irregular dilation and contraction of the pupils and can be indicative of several conditions.
[0160] External psychic influences that include surprise, fear and pain also cause the pupils to dilate. A weak light causes the pupils to dilate, while a bright light causes the pupils to contract. In addition, when an individual focuses on a nearby object, for example when reading a book, the pupils converge and contract slightly, which is commonly called an accommodative reflex. Consequently, since certain factors are known to cause a specific pupillary reaction in otherwise healthy eyes, capturing the pupil's reaction can be used as a means of control. For example, if a pupil contraction is detected alone or in combination with convergence, then the system controller can send a signal to an actuator to change the state of a variable powered optical device embedded in the powered contact lens.
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83/114 [0161] Now with reference to Figure 24, an energized contact lens with a pupil diameter sensor is illustrated. The 2400 contact lens is positioned in an individual's eye 2401. The iris of eye 2401 is shown in two levels of diameter: contracted 2403 and dilated 2405. The contact lens 2400 covers a portion of eye 2401 that includes the iris. The 2400 contact lens includes a first example pupil diameter sensor 2402 and an electronic component 2404. The contact lens 2400 may include other sensors, as discussed in this disclosure.
[0162] In at least one example, the pupil diameter sensor 2402 is positioned on the contact lens 2400 above the iris. As illustrated, pupil diameter sensor 2402 is a thin strip that covers all possible pupil diameters that allows it to detect all levels of a pupil diameter. If implemented as a strip, as in this exemplary embodiment, the strip is preferably thin and transparent so as not to interrupt an incident light in the eye 2401. In at least one exemplary embodiment, the pupil diameter sensor 2402 includes an arrangement photodetectors facing backwards or towards the iris. Depending on the pupil diameter, sensors at varying distances from the center of the iris will detect different reflected lights. For example, when the iris is dilated, most sensors can detect low light because of the large, dark pupil. Conversely, when the iris is contracted, most sensors can detect a greater intensity of light because of the reflection of the iris. It should be understood that, for such a sensor, an ambient light level and an iris color may need to be considered in the system design, for example, by user programming and / or calibration. Such an ambient light sensor can be implemented as a forward-facing photosensor to complement the sensors facing the iris of a
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84/114 pupil diameter sensor 2402. To minimize interruption of the optical zone in front of the eye, at least in an exemplary modality, the pupil diameter sensor 2402 can be implemented with the use of transparent conductors, such as indium- tin and small and thin silicon photosensors.
[0164] In an alternative exemplifying embodiment, pupil diameter sensor 2402 can be implemented as an array of sensors positioned around the iris to maximize coverage as opposed to just a linear strip. It should be understood that other physical configurations are possible to maximize performance, cost, comfort, acceptance and other metrics.
[0165] The pupil diameter sensor 2402 can be integrated with other electronics, can work by itself or can connect to another device, such as a controller portion of the electronic component 2404. In this example mode, the system controller samples the pupil diameter sensor 2402 and, depending on the results of pupil diameter sensor 2402, can activate another component in the system (not shown) and / or used to monitor a user's medical or health condition. A power supply (not shown) supplies current to the pupil diameter sensor 2402, the controller and other components of the electronic ophthalmic system.
[0166] Such a system may require not only detectors, such as the ones illustrated and described, but also emitters (not shown). Such emitters may, for example, include light-emitting diodes corresponding to the photosensors of a pupil diameter sensor 2402. Alternatively, the emitters may include piezoelectric ultrasonic transducers coupled to ultrasonic receivers in the pupil diameter sensor 2402. In yet another embodiment example, sensors and emitters can create a system
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85/114 impedance detection, for example, by passing a low current signal through the eye and measuring changes in voltage across the eye.
[0167] Figure 25 illustrates a 2500 contact lens with an alternative pupil diameter sensor. The 2500 contact lens is positioned in an individual's eye 2501. The iris of eye 2501 is shown in two levels of diameter: contracted 2503 and dilated 2505. The contact lens 2500 covers a portion of eye 2501 that includes the iris. Instead of the strip or array of detectors that partially cover the pupil as described above and illustrated in Figure 24, the system in Figure 25 positions the pupil diameter sensor or sensors 2502 outside the maximum pupil diameter 2505, but still within the 2500 contact lens. This configuration is beneficial because there is no potential obstruction of the optical zone due to the 2502 pupil diameter sensor. The 2502 pupil diameter sensor or sensors may, for example, include a spiral antenna of one or multiple turns. Such an antenna can receive electromagnetic radiation from the eye as the muscles that control the iris contract and relax. It is well known in the relevant art that a neural and muscular activity of the eye can be detected through changes in electromagnetic emissions, for example, with contact electrodes, capacitive sensors, and antennas. In this way, a pupil diameter sensor based on a muscle sensor can be implemented. The pupil diameter sensor 2502 can also be implemented with one or more capacitive or contact electrodes designed to measure impedance across the eye. Similar to other proposed systems that use changes in impedance to determine ciliary muscle activity in the eye, and then a desire to change a focal state, impedance can be used to detect changes in pupil diameter. For example, the impedance measured at 870170039233, of 06/08/2017, p. 90/437
86/114 the iris and pupil can change appreciably depending on a pupil diameter. A pupil diameter sensor 2502 placed at the appropriate location in the eye and properly coupled to the eye can detect these impedance changes and then a pupil diameter. The 2500 contact lens may also include an electronic component 2504 as described above.
[0168] In at least one exemplary embodiment, the system illustrated in Figure 19B has a 1902 sensor which is a pupil diameter sensor, as shown in Figures 24 and 25. A 1902 pupil diameter sensor includes one or more of the sensors of pupil diameter as previously described, for example, photosensors, antennas, or impedance sensors. In at least one example, any emitters needed to implement or improve the performance of the sensors are included in element 1902 for simplicity. The 1902 element can include multiple sensors, or multiple sensor blocks like 1902, perhaps implemented in different sensor technologies and methods. The 1904 signal processor is an interface between the 1902 sensor and the 1906 system controller. The emission of the 1904 signal conditioning element is a signal comprised of sensor data that is inserted into the 1906 system controller. The 1906 system controller , as discussed earlier, can consider inputs from multiple 1902 sensors (both in terms of number and type) to provide an output to the 1908 alert mechanism. A 1910 transceiver can be included in the system to send data to external devices and / or receive data from them, for example, a second contact lens mounted on the adjacent eye, glasses lenses, a smart phone, or another device. Such communication takes place via a 1912 antenna, perhaps an electromagnetic antenna or a combination of light emitting diode / photodiode sensor.
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87/114 [0169] Figure 26 illustrates ambient light 2602 and pupil diameter 2604 plotted versus time on the X axis, which illustrates how the differences between these two measured quantities can be used to activate an electronic ophthalmic device such as a lens. contact. During the first time period 2601, the ambient light level 2602 increases while a pupil diameter 2604 decreases. An ambient light and a pupil diameter can be captured as previously described, for example, by a photodiode facing forward and an impedance sensor facing the iris, respectively. As is commonly the case, as ambient light increases over a 2601 period of time a pupil diameter decreases. This is a common reaction that occurs to maintain a relatively constant light intensity on the retina by reducing the opening of the iris. Over a period of time 2603, the ambient light level 2602 first continues to increase and then levels off. However, pupil diameter 2604 contracts more quickly than in the previous period of time. This is not the classic correlation between ambient light and a pupil diameter. This response may be caused by a narrow-angle pupil response, perhaps to a closed book, versus the wide-angle response to the wide-angle response. In this way, a change in a pupil diameter response can be detected and used to activate a function in an electronic ophthalmic device. Over a period of time 2605, ambient light 2602 remains constant, however, pupil diameter 2604 dilates or increases. Again, this can be caused by a specific response in the eye, for example, the accommodation reflex. In a period of time 2607 there is again a difference between an ambient light level 2602, which starts to level and then decreases, and a pupil diameter 2604 which remains constant. Again, this can be used to detect certain responses in the eye and trigger changes in the operation
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88/114 of an electronic ophthalmic device. Finally, in a period of time 2609 the classic response is again observed to be similar to that shown in a period of time 2601. As the ambient light level 2602 decreases, pupil diameter 2604 expands to let in more light.
[0170] In at least one example mode, the activities of the signal conditioning block and the system controller (1904 and 1906 in Figure 19B, respectively) depend on the available sensor inputs, the environment, and user reactions, for example, the level of ambient light and a pupil diameter as shown in Figure 26. Entry, reaction and decision thresholds can be determined from one or more ophthalmic research, pre-programming, training and adaptive / de learning. For example, the general characteristics of pupil dilation versus ambient light can be well documented in the literature, applicable to a wide population of users and pre-programmed in a 1906 system controller. However, an individual's deviations from the expected response in In general, for example, the deviations illustrated in time periods 2603, 2605, and 2607 of Figure 26, can be recorded in a training section or part of a learning / adaptive algorithm that continues to refine the response in a device operation electronic ophthalmic. In an exemplary mode, the user can train the device by activating a remote fob control, which communicates with the device, when the user wants close focus. A learning algorithm on the device can then reference the sensor inputs in memory before and after the fob remote signal to refine the internal decision algorithms. This training period could last for a day or any other suitable period of time, after which the device would operate autonomously with only the inputs
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89/114 sensor and without the need for the remote fob.
[0171] In an additional exemplary embodiment, the pupil dilation sensor is used in combination with the photodetector sensors for blink detection to provide the user with a light activated pupil dilation test. In at least one example, the system controller monitors a photodetector sensor for a rapid change in the light level that would be of sufficient size to cause an enlarged pupil. In such an embodiment, the system controller could also monitor the pupil dilation sensor (s) to determine the pupil size, so that there is a possible comparison to detect the change in pupil size when a rapid change of the pupil. light level is detected. The system controller would have a model that includes a light shift threshold and a pupil dilation threshold for comparison with stored data, for example in recorders or memorials) buffer in the system controller. When the light shift threshold is reached and the threshold pupil dilation threshold is not reached, then the system controller will determine that a medical condition has occurred for the user. The change would be a comparison with a recent sensor reading with the current sensor reading. In at least one example, the recent sensor reading is a reading made within a predetermined period of time, to compensate for an implementation where there is a high sampling rate of the sensors. In an alternative exemplary mode, the system controller can also store relevant data when both thresholds are exceeded, particularly in a medical record implementation.
[0172] In at least one example, the energized or electronic ophthalmic lens includes a pulse oximeter sensor that faces the iris. The pulse oximeter sensor includes
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90/114 at least one light source, such as an LED, and at least one photosensor to receive the reflected back light from the eye that originates with the light source. Figures 27 and 28 illustrate an example lens 2700 having the 2710 pulse oximeter sensor and a 2730 system controller. The illustrated 2710 pulse oximeter sensor includes at least one 2712 light source and at least one 2714 photosensor. the light source 2712 as the photosensor 2714 are in electrical communication with a signal processor 2716 which processes the output of the photosensor 2714 and activates the light source 2712, for example, with an oximeter signal. The 2716 signal processor provides an output to the 2730 system controller. In at least one exemplary embodiment, the 2716 signal processor is incorporated into the 2730 system controller. As discussed in the various other exemplary embodiments of the present invention, there may be a variety other components present in the 2700 contact lens in addition to these components.
[0173] In at least one exemplary embodiment, the light source includes an infrared light source and / or a proximal infrared light source. In at least one example, when the light source is a light emitter, then it is configured to emit light with two wavelengths. The first wavelength is about 660 nm, while the second wavelength is about 940 nm. In an alternative exemplifying embodiment, in which the light source includes two light emitters, the first light emitter produces light with a wavelength of about 660 nm, and the second light emitter produces light with a wavelength of about 660 nm. wave in the range of about 950 nm to about 890 nm. In another example, the light source (or sources) has a bandwidth in the range of 20 nm to 50 nm.
[0174] In at least one exemplary modality, fotosPetição 870170039233, of 06/08/2017, p. 95/437
91/114 sensor is selected from any of the photodetectors discussed earlier in this disclosure. The photosensor can be matched to the light source, for example, having a peak response wavelength close to the source's output wavelength, and a similar bandwidth.
[0175] In at least one example mode, as shown in Figure 28, the communication system additionally includes a 2870 communication circuit that allows the transmission of the photodetector output to be sent to an external device for processing.
[0176] In at least one exemplifying modality, the light source and the photodetector are arranged to perform pulse oximetry by reflectance based on the proximity between them. In at least one alternative exemplary embodiment, the light source and the photodetector are arranged to be on opposite edges of the contact lens to provide the transmission of pulse oximetry through the passage of light through the user's cornea and iris. Its location on opposite edges is so that the sensor and the light source are adjacent to the edge to allow for the presence of a sufficient amount of lens material between them and the edge for manufacturing and / or safety considerations.
[0177] In at least one exemplary modality, as shown in Figure 29, the 2900 contact lens includes a 2910 sensor to detect at least one of the removal of a case for storing contact lenses and insertion of the lens in the user's eye . In at least one exemplary modality, the insertion of the contact lens in the user's eye will activate medical monitoring by the 2920 system controller. In an additional exemplary modality, the insertion will initiate the execution of an accumulator in the 2922 alert mechanism. an exemplifying modality alPetição 870170039233, of 06/08/2017, p. 96/437
92/114 ternatively, removing the contact lens from the user's eye will terminate medical monitoring by the 2920 system controller. Examples of sensors that would provide detection include, but are not limited to, a pressure sensor, a reed relay, a sensor of salinity, a biosensor and a capacitive sensor. These sensors, in at least one example, work in conjunction with a light sensor to detect the presence of light that occurs after removing the contact lens from the storage container. In an exemplary modality in addition to the sensor modalities, the sample rate used to monitor the sensor can be reduced after the detection of the event being monitored to save energy, while making it possible to detect the removal of the eye contact lens. In an exemplary modality alternative to the previous modality, the sensor would be disabled when it detects the contact lens being placed in the eye.
[0178] The pressure sensor can take a variety of forms. An example is a pressure sensor facing the iris (or facing backwards) connected to the system controller via an analog-to-digital converter. The pressure sensor facing the iris, in at least one example, is partially encapsulated in the contact lens, while the analog-to-digital converter is completely encapsulated in the contact lens and included as part of any circuit board present in the contact lens. contact lens. The system controller resets the accumulator when it receives a signal from the pressure sensor above an insertion threshold, indicating that data collection should begin with the system controller. The system controller sends a signal to the alert mechanism to store the current value of the accumulator when the pressure sensor signal falls below the insertion threshold, indicating that the contact lens has been removed and that additional data collection is unnecessary. The controller
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93/114 system samples the pressure sensor on a predetermined schedule only when the system controller detects that the eyelid is open. Another example of a pressure sensor is a pressure sensor that will detect the removal of pressure from the saline present in the storage container and would provide a signal to activate the other contact lens functionality. An additional example of a pressure sensor is a surface acoustic wave resonator with interdigital transducer (IDT, interdigital transducer). Yet another example is a binary contact pressure sensor that detects pressure or non-pressure, but not the pressure level.
[0179] An example is the use of a reed relay that completes a circuit in the contact lens that supplies power to the other elements of the circuit by applying pressure from the user's eye when inserting the contact lens, or removing pressure when the lens contact is removed from the storage container for use. After the respective event occurs, the reed relay would close and complete the circuit to provide an electrical connection between the system controller and the power supply. Another example of using a reed relay in the system is to provide a binary output when the switch is activated, with the binary output providing an indication that the switch is being closed (or opened, depending on the orientation of the switch) as opposed to closing a circuit .
[0180] A salinity sensor or biosensor in at least one exemplary modality would detect the salinity or other chemical present in the tear fluid. Examples of substances that could be monitored include, but are not limited to, a pathogen, a biomarker, an active agent and a chemical. An example of a biosensor is a resistance guide, in electrical communication with the system controller, which is able to bond with the substance being monitored, resulting in a growing resistance. 870170039233, 06/06/2017, p. 98/437
94/114 increases or decreases as the amount of the substance present increases and / or decreases. Another example is a reagent tube that contains a substance, material or mixture that reacts with a specific molecule where a reaction will be indicative of the presence of a chemical being monitored. Yet another example is a biosensor in which a surface is functionalized to have an affinity for a certain substance, and an electrical property of the sensor, for example, capacitance or voltage, varies in response to the presence of the substance for which the sensor is functionalized. In at least one exemplary modality, when a chemical being monitored refers to a concentration of some substance in the tear fluid, the reaction can occur directly with the substance or it can occur with a separate substance that can indicate the concentration of the monitored substance. In other examples, because other electroactive biological components can affect conductivity within a specific tube, the tube can be aligned or comprise a selective barrier to minimize interference with substances other than the substance being monitored. Alternatively to a tube having an increasing conductivity in response to the presence of the monitored substance, the tube may have an increasing resistivity in the presence of the monitored substance. Another example will have the concave tube including material that is selectively permeable or attractive to a specific substance or chemical. Under any of these examples, it may be possible to provide a graduated indication at the substance level in addition to a binary output. In at least one exemplary embodiment, the salinity sensor and / or biosensor is one of the sensors 110 ', 120' in Figures 1Ae1Da1F used by system controller 130 to monitor at least one medical condition or user state.
[0181] The capacitive sensor can be turned back or turned
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95/114 forward. In at least one example, the sensor would be a sensor facing the iris to enable contact by the user's eye. In another example, when the contact causes a change in capacitance above an insertion threshold indicating that the contact lens has been inserted, the sensor is disabled or has a reduced sampling rate. If, however, the sensor was facing forward, then contact by one of the eyelids that would change the capacitance above the insertion threshold would confirm the insertion of the contact lens. In another example, the forward-facing capacitive sensor would also be used to detect the position of the eyelids.
[0182] In complex systems that may include multiple sensors, such as energized ophthalmic lenses that have several electronic components, it is possible, in at least one mode, to reduce the potential for initiating false actions or false positive triggering of a sleep determination. According to another alternative exemplifying modality, this exemplifying modality is directed at a decision-making process and / or voting scheme that uses input from multiple sensors to substantially reduce the possibility of changing the state of the energized ophthalmic lens based on information inaccurate, incomplete or wrong, varying psychological conditions, as well as noise and / or interference from internal and external sources. For example, in medical monitoring, the control system should not determine the onset of a medical condition, such as a seizure, based on a random blink pattern due to irritation of the eye or the like. Similar to medical monitoring, a determination of concussion or mental degradation should not be confused with slow eye movements (drowsiness) or fixed eye movements (daydreaming). However, with the input of a single sensor or wrong information
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96/114 of the single sensor or other sensors, incorrect decisions can be made by the system controller. For example, without knowing the pressure applied to the ophthalmic lens, simply closing the eyelids can trigger a sleep determination, even though the user scratches his eyes and applies more pressure than the eyelid pressure on a pressure sensor (s) . In an energized ophthalmic lens that has an eyelid position sensor, the movement of the eyelid can also be used as a trigger to make a sleep determination. For example, when an individual looks down to focus on an object at a close distance, the eyelids tend to droop and thus can be used to change the state of the ophthalmic lens. Again, if only a single entry is used, a false action can occur due to the fact that the individual is drowsy and his eyelids drooped. All of these sensors can be used as action triggers to be implanted by various systems incorporated into an electronic or energized ophthalmic lens, and all are independently or in limited combination, potentially subject to error. In addition to the aforementioned sensors that are designed to detect certain aspects directly related to determining sleep onset, other sensors can be used to optimize sensors for state changes by monitoring ambient conditions, noise, and interference. For example, ambient light can be monitored to optimize the accuracy of blink detection sensors, eyelid position and pupil diameter. Such sensors can be used to augment other sensors, for example, by subtracting mode noise and interference. Sensor inputs can be used to record historical readings (an example of historical data) which are then considered by a complex decision algorithm, for example one that considers accelerometer inputs and eye muscle contractions for deposition 870170039233 , of 06/08/2017, p. 101/437
97/114 finish the position of the pupil. The use of the voting scheme according to at least one example mode can reduce the likelihood of error when determining whether the user has fallen asleep, and can also allow for more accurate measurements. In other words, for any given determination to be made, there are sensors that can be used to verify confirmatory evidence or to increase input for a given determination by a primary sensor. It is also important to note that the detected data, in additional or alternative use, can simply be used as part of a collection process instead of a triggering event. For example, the detected data can be collected, stored and used in the treatment of medical conditions. In other words, it should be understood that a device that uses such a sensor may not change the state visibly for the user; instead, the device can simply record data.
[0183] Now with reference to Figure 30, a generic system is illustrated in which sensors 3002, 3004, 3006 and 3008 are used to determine whether a medical condition has occurred. Sensors 3002, 3004, 3006 and 3008 can include any number of possible inputs including blinking, eyelid position, pupil position, contact lens orientation, external lens pressure, biosensors, bioimpedance, temperature, pulse oximeter, and the like. The number and type of sensors are determined by the application and the user. Each sensor 3002, 3004, 3006 and 3008 can have its own signal conditioning contained inside the sensor block, a dedicated block or inside the 3010 system controller. The 3010 system controller accepts inputs from each sensor 3002, 3004, 3006 and 3008. It then performs routines to process and compare the input data. Based on these inputs, the 3010 system controller determines whether the 3012 alert mechanism should
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98/114 record any readings. For example, the combination of eyelid tilt, low ambient light and vertical lens orientation can trigger the 3010 system controller to determine that the user is drowsy and signal the 3012 alert mechanism to increase the sample rate by at least a sensor system being used to make the determination. Likewise, the combination of eyelid closure, vertical user orientation, and external eyelid pressure can trigger the 3010 system controller to determine that there is no sleep and continue normal operation. The combination of eyelid closure, horizontal user orientation can trigger the 3010 system controller to determine the onset of sleep and signal the alert mechanism to record data as likely intentional sleep, taking into account the user's guidance. Inputs from multiple sensors can also be used to change the configuration of the system controller to optimize decision-making performance, for example, if the ambient light decreases, the controller can increase the gain of a photosensor. The system controller can also turn sensors on / off, increase and / or decrease sample rates and perform other changes to optimize performance. The use of inputs from multiple sensors in conjunction with an algorithm that weighs and / or votes in various scenarios tends to minimize false positives, thus tending to make the system as a whole more reliable.
[0184] Figure 31 illustrates a flow chart of a method by which a system controller, for example, the 3010 system controller illustrated in Figure 30, operates to take samples from the sensors and determine if a medical condition has occurred. The first step is to take samples from the 3102 sensors. This may require the activation of other elements to activate, heat, calibrate, take read data. 870170039233, from 06/08/2017, p. 103/437
99/114 ras, conditioning and output. The system controller can also provide configuration information for each sensor based on programmed values and current data, for example, the gain of a photosensor amplifier based on the incident light history, or these settings can be determined by other elements in the system. The method then performs additional filtering and conditioning, 3104, for example, digital as opposed to analogous filtering, along with a comparison to the baseline or reference results. One purpose of this step is to properly condition the input data for the next step so that an accurate decision can be made that can be repeated. Then the results are determined from each sensor, 3106, for example, the position of the eyelid and the response of the emitting detector. This determination may involve comparison to a pre-programmed or variable threshold, comparison to a specific pattern, or any other determination. The results are aggregated from the previous step and weighted 3108. A decision on the occurrence of a medical condition is made using, for example, a model 3110. This step, in at least one example, can involve training and preferences or historical data for each user, ensuring that all sensors have been sampled before making a decision, and applying various weights to the results of each sensor. In the same modality, a decision is made being predictable and can be repeated in the presence of noise and interference from the real world. If a decision is made regarding a medical condition as described above, then data recording, 3112, can be started. Regardless of the decision, return the system to sampling so that another set of measurements and determination can occur 3114. The total time required to perform the process in Figure 31 is, in at least one mode
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100/114 example, short enough for the system to be responsive to user input similar to the way individuals interact naturally with their environments.
[0185] It should be understood that each sensor input can vary for reasons other than monitoring. For example, the impedance of the eye can vary over time due to changes in the body's hydration, salt intake, level of effort, or other means. Similarly, the pupil diameter may vary due to changes in ambient light levels. Thus, it should be evident that the combination of multiple sensor inputs reduces the chances of false positive triggering by requiring more than one input to correlate to a desired change in focal length or by using certain sensor inputs to increase others sensors.
[0186] It should also be evident that problem models such as limits and / or problem patterns for each sensor and the combination of sensors used to monitor the user depend on many variables such as security, response time and user preferences. The specific programming of the voting scheme can be based on clinical observations from several individuals and the individual programming adapted for a specific user based on at least one example model, for example, on recent sensor readings and / or historical data, which can be discharged onto the lens (s). The parameters in the voting scheme may depend on sensor inputs, for example, the threshold and gain setting for blink detection may vary with ambient light.
[0187] In an alternative example mode, the system additionally includes a memory preservation controller that is in electrical communication with the power source and the system controller. In at least one exemplary modality, competition 870170039233, of 06/08/2017, p. 105/437
101/114 memory preservation controller is an example of the resource management system 160 discussed in connection with Figure 1B. The memory preservation controller, at a predetermined frequency, tests the power source to determine the remaining energy level. When the remaining energy falls below a predetermined energy limit, the memory preservation controller sends an instruction to the system controller to no longer take samples from the sensor and send a signal that causes the current time alert mechanism to register and / or the value of the accumulator. The power is then supplied to maintain the data in memory and / or data storage present in the contact lens. In an additional example mode, when the power supply finds the available energy level below a lower energy threshold, the system will perform at least one of the following actions: reduce the sampling rate of at least one sensor, interrupt sampling additional monitoring of at least one sensor, interrupt additional monitoring of the power supply, store the timestamp representing the low energy based on the current value in the accumulator or timing circuit, remove power from at least one sensor, perform sampling at least one sensor at a second sampling rate that is slower than the first sampling rate, energizing a memory where the readings are stored, or any combination of these actions. Based on this disclosure, the person skilled in the art will recognize that a specific implementation may have only one of these options available and that it is contemplated to be covered by at least one language.
[0188] The predetermined energy threshold is based on an estimate of the energy needed to maintain a power supply for any memory or data storage device.
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102/114
In another exemplary modality, the threshold is adjusted based on the current execution period of the lens while still facilitating an estimated period of energy for memory and / or data storage. An example of how to adjust the threshold over time is to decrement a recorder for each pass of a given time measured by sampling periods on the contact lens.
[0189] In another example, the energy level test is done in conjunction with the sampling of the sensor (s) to compare the energy level of the energy source with the threshold under maximum lens load, such as occurs when one or more sensors are providing one or more readings. If the energy level for the energy source is below a threshold, then there is a high probability that a next sampling of the sensor, before the next energy level test, will drain the energy source so that the (s) sensor (s) provide an incorrect reading because of insufficient available energy, and / or the stored data becomes corrupted, thus leading to an unreliable data set. [0190] In a modified alternative exemplary mode, the memory preservation controller places an artificial charge on the power source during periods of non-sampling of the sensor (s). Exemplary sampling times include, but are not limited to, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes. Other examples for testing the power source include, but are not limited to, obtaining a charged voltage, introducing a special test waveform to pulse the current out of the battery and measure the voltage drop by comparing the results being compared with a predetermined threshold, which in another example mode can be adjusted upstream in view of the remaining expected execution time.
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103/114 [0191] In another alternative example mode, the memory preservation controller monitors the data manager to determine the remaining space. When the remaining space in the data manager's memory is less than a free space threshold, the memory preservation controller sends a signal to the system controller to perform at least one of the following actions: end sampling of the (s) sensor (s) to avoid creating additional data for storage, send a signal to the data store to set a memory full indicator and toggle the currently stored data to provide additional space using a first in, first out approach, and remove power from the system controller and sensor (s) leaving power only to the data store. Other examples include storing a timestamp representing low memory based on the current value in the accumulator, reducing the sample rate for at least one sensor, stopping additional sampling of at least one sensor, storing future readings of at least minus one sensor over the first readings stored in memory, delete the stored sensor readings associated with the lowest accumulator reading and move the remaining stored sensor and accumulator readings into memory, and any combination of these examples.
[0192] In an exemplary modality in addition to the above exemplary modalities, the memory preservation controller and / or the resource management system are part of the system controller.
[0193] In at least one example, the electronic elements and electronic interconnections are produced in the peripheral zone of a contact lens and not in the optical zone. According to an alternative example, it is important to note
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104/114 that the positioning of the electronic elements need not be limited to the peripheral zone of the contact lens. All electronic components described here can be manufactured using thin film technology and / or transparent materials. If these technologies are used, the electronic components can be placed in any suitable location, as long as they are compatible with the optical elements.
[0194] An intraocular lens or IOL is a lens that is implanted in the eye and replaces the lens of the lens. It can be used for individuals with cataracts or simply to treat various refractive errors. An IOL typically comprises a small plastic lens with plastic side supports called haptics to hold the lens in the position of the capsular pouch in the eye. Any of the electronic elements and / or components described here can be incorporated into IOLs in a manner similar to that of contact lenses.
[0195] In at least one example, the system additionally includes a storage box. In at least one embodiment, the storage box includes a compartment with a base and a lid, which are connected along an edge to facilitate opening the lid in relation to the base, in order to allow contact lens deposit in a cavity in the compartment. In alternative exemplifying modalities, the storage box may include disinfection, monitoring, reorganization and external connectivity functionality. The disinfection functionality would enable the lens to be used over an extended period of time by the user.
[0196] Figure 32 illustrates an exemplary storage box that has a 3200 compartment, a 3202 communication system, a 3204 system controller, a 3206 memory, a clock (or timing circuit) 3208, an electrical communication connector 870170039233 , of 06/08/2017, p. 109/437
105/114 3210 and a 3212 power source. In an alternative exemplary embodiment, the storage box includes a 3214 radiation disinfection base unit contained within a 3200 compartment that, in at least one exemplary embodiment, includes a base and a cover. The 3210 electrical communication connector can include a USB connector or other type of connector. The connector can include a terminal for transferring one or both of the electrical data energies. In some exemplary embodiments, the 3210 electrical communication connector provides power to operate the 3214 radiation disinfection base unit. Some embodiments may also include one or more 3212 batteries or other energy storage devices. In some exemplary embodiments, 3212 batteries include one or more lithium-ion batteries or other rechargeable devices. The energy storage devices can receive a charged electric current through the 3210 electrical communication connector. In at least one battery mode, the 3214 radiation disinfection base unit is operational through the energy stored in the 3212 batteries.
[0197] In at least one example, the communication system 3202 includes an antenna, such as a radio frequency identification (RFID) antenna to interact with the inserted lenses and the system controller 3204 that communicates electrically with said antenna. In at least one example mode, controller 3204 is in electrical communication with at least one device or memory element 3206, which in at least one mode is flash memory like that used on a memory stick. Examples of the interaction include wireless recharging of the power source in one or both lenses, transferring the current time, transferring the alarm time, transferring the Petition 870170039233, 06/06/2017, p. 110/437
106/114 of those stored in one or more lenses for memory in (or in communication with) the storage box, and transfer of models and masks, based on the user's specific characteristics, from the storage box to at least one of the lenses . In an alternative exemplary mode, the antenna is used to communicate with an external device, such as a computer or smartphone.
[0198] In at least one example mode, the 3204 system controller is configured to convert and / or format the data received from at least one lens to change the time stamp information in real times based on the current reading of the accumulator at the time of data transfer, as correlated with the current time in the storage box from clock 3208. In an alternative exemplary mode, the storage box sends a signal to the lens to reset the accumulator to zero, and the processor registers in memory the time when the accumulator was reset to zero or, alternatively, updates the accumulator to the correct time. After the lens is reinserted into the storage box, the processor observes the current time and determines the number of sampling cycles. In the modalities where the sampling cycles are of different lengths depending on what is being sampled and / or the operational state of the lens (s) since the removal of the lens (s), the storage box normalizes the periods sample time difference between removing the lens (s) from the storage box and returning the lens (s) to the storage box as measured by the storage box. Alternatively, when the sampling cycles have different lengths, the storage box sends a signal to the contact lens to adjust its oscillator in an amount related to the time deviation displayed by the contact lens and in another
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107/114 exemplary modality, the storage box updates the time in the accumulator present in the contact lens. In an alternative exemplary embodiment, the processing described above is performed on an external device, such as a computer.
[0199] In some exemplary embodiments, the 3210 electrical communication connector may include a single source of alternating current or direct current. In such embodiments, the power source 3212 can be omitted, since power is supplied through the electrical communication connector 3210.
[0200] In at least one exemplary modality, the contact lens will collect data regarding the medical condition over the period of time (for example, 8 hours, 12 hours, 16 hours, 24 hours, one day of use). When the contact lens is placed inside the storage box (or another device with similar functionality), data is transferred from the lens to the storage box for analysis and processing by the storage box or by a computer communicating with the box of storage. An example of analysis and processing is to determine if a medical condition has arisen during the time period.
[0201] In at least one example, there is a test protocol for a user (or patient) of at least one contact lens using an external device. In at least one exemplary embodiment, the contact lens may have a variety of component combinations, as discussed in this disclosure. For the purposes of this discussion, the contact lens will include an eye movement sensor system, a system controller and a communication circuit configured for bidirectional communication with the external device. In at least one example mode, the external device will include a processor configured to execute a test protocol, a camera in communication. Petition 870170039233, of 06/08/2017, p. 112/437
108/114 tion with the processor, a display in communication with the processor and configured to display images and instructions, and a communication module configured for bidirectional communication with the contact lens. In another example, the camera and the display will face the same direction. In at least one example embodiment, the system controller is configured to determine the movement of the eye, and / or the direction of the look based on a spatial location provided from the eye movement sensor system and to provide a control signal based on the determination. In at least one example embodiment, the output from the system controller is a formatted signal for transmission to the external device for processing and determining the location of the eye. In at least one example mode, the processor and the system controller together execute the test protocol. As should be understood based on this disclosure, the eye movement sensor system can be expanded to include other sensors or replaced by one or more other sensors.
[0202] In at least one example, the test protocol causes the processor to correlate the movement of the external device by the user (or someone else) of the contact lens with the information received about the location of the eye and / or the look transmitted by the system controller through the circuit and communication module. The processor uses the image data captured by the camera to monitor the movement of the individual's head. When at least one event of non-correlation or movement of the individual's head occurs, the processor is configured to trigger an alarm, for example, the activation of the display, the speaker, the flashlight, or a combination thereof or the sending of signal to another device. The processor displays instructions to the individual on the movement of the external device and maintenance of viPetição 870170039233, of 06/08/2017, p. 113/437
109/114 visualization of the external device without moving its head. In an alternative exemplary mode, the external device turns on its flashlight to provide a light for the contact lens user to follow as a guide or display a message or image on the display. In an alternative exemplary modality, a person other than the user of the contact lens moves the external device, which in such a modality would allow the use of an external device in which the camera and display are facing opposite directions. In another alternative exemplary mode, the external device uses, instead of or in addition to the display, the speaker to provide instructions.
[0203] In another example, where the external device includes an accelerometer, the processor is configured to use an accelerometer output in conjunction with a camera output to determine whether the user's head is stable while the external device is moved substantially in a straight line in a horizontal plane in front of the user. This accelerometer data is compared with contact lens location / movement information to determine if any difference exceeds a threshold, which, if exceeded, would trigger an alarm. In at least one exemplary modality, contact lens data is normalized in relation to the distance traveled by the external device or vice versa to take into account that the external device will travel a greater absolute distance in relation to the movement of the user's eye.
[0204] In an alternative exemplifying mode, the user is instructed to focus on a stationary object and, while maintaining focus on the stationary object, to turn his head to the left or to the right. A monitoring system tracks the user's eye in relation to the user's head
Petition 870170039233, of 06/08/2017, p. 114/437
110/114 determine if the differential is within a predetermined turn threshold, and initiate an alert when the turn threshold is exceeded. Examples of alert initiation include triggering the alert mechanism or sending an alert signal to the external device or other device, which in at least one mode would in turn provide an alert for the user and / or a another person. In another example, the contact lens uses an output from at least one accelerometer in which the differential is determined based on an accelerometer signal, where the sign equal to zero is the confirmation of the tracking of the stationary object by the user, whereas when the signal is a non-zero value, there is a delay by the user in tracking the stationary object. In at least one example, this test protocol is performed without an external device.
[0205] The test protocol above can be used in diagnostics, for example, a stroke. The ability or inability to track an object and / or a fixed point can be a sign of other medical conditions.
[0206] An additional test protocol includes testing the pupil dilation of the user's eye, which can be used independently or in conjunction with the previous test protocol. The contact lens will include a pupil diameter sensor facing the iris in communication with the system controller. The external device will include a light source like the flashlight that is controllable by the processor. The test protocol includes activation of the light source by the processor, measurement of pupil diameter by the system controller before and after activation of the light source, transmission of pupil diameter measurements to the processor, determination of different pupil dilations by processor, and trigger an alert when at least one pupil dilation exceeds a threshold or is less than one
Petition 870170039233, of 06/08/2017, p. 115/437
111/114 undilated threshold. In another example, the contact lens includes a photodetector to measure the light level of the light sensor output to confirm that a required level has been satisfied after activation. In an alternative exemplary mode, the external device provides instructions for looking at bright light (instead of activating the light source) and the system controller uses detection of the light level of the photodetector to confirm that it is bright enough to trigger the expansion. In another alternative exemplary modality, the contact lens with a photodetector monitors the level of ambient light and when bright light is detected as being observed by the user, the system controller determines whether the change in pupil diameter in the states before and after exceeds the dilation threshold. In another alternative exemplary mode, the system controller uses a light source facing the iris on the contact lens to be activated and provide light with enough brightness to trigger pupil dilation in a conventional user.
[0207] Pupil dilation can be used to detect, for example, a concussion or intoxication of the contact lens wearer. In addition, as briefly described above, the pupillary response can be used to diagnose cranial nerve damage. More specifically, in much the same way that a visual care professional can assess the pupil and iris, sensors can be used to check for direct light reflection, consensual light reflection and convergence / accommodation reflection. For example, in Argyll Robertson's disease, the pupil contracts to accommodate, but does not respond to light. The ability of the contact lens to detect the amount of change in pupil dilation in response to bright light (or a rapid change in ambient light) that shines in the contact lens wearer's eye can be used to determine whether it has occurred
Petition 870170039233, of 06/08/2017, p. 116/437
112/114 a concussion or if the user is intoxicated. If the change in pupil dilation in response to a change in light is excessive, this is an indication of sensitivity to light, which, in turn, is an indication of other possible medical conditions. In at least one implementation, a contact lens wearer can check whether they are possibly intoxicated before driving based on the dilation test. As mentioned above, the pupil dilation test can be used in conjunction with the test protocol to track a point with the eyes as the point and / or the head moves.
[0208] The various test protocols and the monitoring of the contact lens capabilities can be initiated, terminated etc., by data entered by the user through the use of flashes, light or other wireless communication, and the insertion / removal of the contact lens.
[0209] The contact lens described above and combinations of sensors can be used for a variety of purposes and the detection of medical conditions, some of which are discussed above.
[0210] As a corollary of the pupil dilation test, pupil contraction should be measured including the time required for the pupil to readjust after the incidence of bright light on it. If the adjustment time is too long, this may be an indication of concussion or intoxication.
[0211] When the contact lens includes a light source facing the iris and an eyelid position sensor system, then the light source can be used to send light to the iris to cause a reflection of the cornea by the eye. The speed of closure of the eyelid can be compared with a threshold of closure of the eyelid to determine if the response was sufficiently fast and within normal response times.
[0212] When contact lenses include a motion sensor 870170039233, from 06/08/2017, p. 117/437
113/114 of the eye, the contact lens can be used to track the movement of the eye and the eye to determine if there is a match between the user's eyes. If there is no match between the eyes, then this is indicative of nystagmus. In at least one exemplary modality, eye movement, focus and gaze could be tested using the external device as discussed above. The external device would provide the test result in terms of whether the eyes refocused with moving the target at different distances from the eyes to check whether the eyes refocused and moved along a substantially horizontal plane around the eyes to see if both eyes tracked the target without moving their heads.
[0213] When the contact lens includes a biosensor, the biosensor can be used to detect the level of sodium present in the tear fluid and / or the amount of tear fluid present in the eye. When the sodium level in the tear fluid exceeds a sodium threshold or the tear fluid level present is below a burst threshold, then the user may be suffering from dehydration.
[0214] When the contact lens includes a temperature sensor, the system controller is able to monitor the user's body temperature to a decreasing temperature before it reaches hypothermia levels and provide an alarm to the user. On the other hand, the system controller is able to monitor the temperature before it reaches hyperthermia levels and emit an alarm to the user.
[0215] Although shown and described in relation to what is believed to be the most practical modalities, it is obvious that divergences from specific projects and methods described and shown will be evident to those versed in the technique and can be used without deviating from the spirit and scope of invention. The present invention is not restricted
Petition 870170039233, of 06/08/2017, p. 118/437
114/114 to the specific constructions described and illustrated, but must be interpreted in a cohesive manner with any modifications that may fall within the scope of the claims.
Petition 870170039233, of 06/08/2017, p. 119/437
1/14

权利要求:
Claims (36)
[1]
1. Energized ophthalmic lens, characterized by the fact that it comprises:
a contact lens, and an eyelid position sensor system at least partially encapsulated in the contact lens, said eyelid position sensor system configured to detect a vertical eyelid position and a signal conditioner configured to individually sample each individual sensor in said sensor system for detecting the position of the eyelid and providing an eyelid exit signal;
an eye movement sensor system at least partially encapsulated in the contact lens, said eye movement sensor system includes at least one movement sensor to track and determine the position of the eye, and a signal conditioner associated cooperatively with the said motion sensor is configured to track and determine the position of the eye in spatial coordinates, based on information from said motion sensor output, and to provide an outgoing motion signal;
a system controller in electrical communication with said eyelid position sensor system and said eye movement sensor system, said system controller has an associated memory containing a plurality of problem models and at least two sets of registers for storing data received from said eyelid position sensor system and said eye movement sensor system, said system controller configured to compare received eyelid output signal data and outgoing movement signal data with said plurality of problem models and generate a control signal when at least one problem model is satisfied, and at least one alert mechanism in electronic communication. 870170039233, 06/06/2017, p. 120/437
[2]
2/14 with said system controller, said alert mechanism is configured to receive the output control signal and is capable of at least one of the actions of providing an alert and storing data.
2. Energized ophthalmic lens, according to claim 1, characterized by the fact that at least one of the plurality of problem models is based on historical data of an intended user of said lens.
[3]
3. Energized ophthalmic lens, according to claim 1, characterized by the fact that it additionally comprises:
an entry by the user in electrical communication with said system controller; and a storage memory in electrical communication with said system controller, and wherein said system controller includes a buffer memory for storing a plurality of signals from said eyelid position sensor system and said motion sensor system. of the eye, so that upon receipt of a signal from said input by the user, the system controller copies the data in the buffer memory to said storage memory.
[4]
4. Energized ophthalmic lens, according to claim 3, characterized by the fact that said input by the user includes a receiver capable of wirelessly receiving input from an individual to store the data present in said buffer memory.
[5]
5. Energized ophthalmic lens, according to claim 1, characterized by the fact that it additionally comprises:
a receiver in electrical communication with said system controller, said receiver configured to receive a data request from an external device; and
Petition 870170039233, of 06/08/2017, p. 121/437
A transmitter in electrical communication with said system controller and said storage memory, and wherein said system controller in response to a received data request transmits, through said transmitter, the contents of said memory storage to the external device.
[6]
6. Energized ophthalmic lens according to claim 1, characterized by the fact that when said system controller determines an oscillating signal from said eye movement sensor system, said system controller copies the data into the buffer memory to a storage memory.
[7]
7. Energized ophthalmic lens, according to claim 1, characterized by the fact that said eye movement sensor system includes at least one of a photodetector positioned to capture an image of the eye; at least one camera facing the iris configured to detect changes in images, patterns or contrast to track eye movement; at least one accelerometer to track the movement of at least one of the eye or contact lens; and at least one neuromuscular sensor configured to detect neuromuscular activity associated with eye movement.
[8]
8. Energized ophthalmic lens, according to claim 1, characterized by the fact that the eye movement sensor system additionally comprises a signal processor configured to receive signals from said movement sensor, perform digital signal processing and emit one or more signals to the system controller.
[9]
9. Pair of lenses, characterized by the fact that it comprises:
the energized ophthalmic lens, as defined in claim 870170039233, of 06/08/2017, p. 122/437
4/14 tion 1, wherein the eye movement sensor system further comprises a communication system for communicating with at least a second contact lens, said second contact lens has an eye movement sensor system incorporated in the contact, the eye movement sensor system includes at least one sensor to track and determine the eye position, and a signal conditioner co-operatively associated with the sensor and configured to track and determine the eye position in spatial coordinates, based on in the sensor output information and provide an output movement signal;
a system controller in electrical communication with said eye movement sensor system, and a communication system for communicating the output of the eye movement sensor system to said first contact lens.
[10]
10. Pair of lenses, according to claim 9, characterized by the fact that when said system controller in said first contact lens detects divergence of sight lines from the user's eyes, said system controller sends the control for said alert mechanism.
[11]
11. Pair of lenses, according to claim 9, characterized by the fact that each lens additionally includes a pupil diameter sensor facing backwards in electrical communication with said system controller, said pupil diameter sensor facing back to measure the pupil diameter;
said system controller of said second lens is configured to transmit said pupil diameter measurement by means of said communication systems to said system controller of said first lens, so that said system controller of the priPetition 870170039233, of 06/08/2017, p. 123/437
5/14 The first lens is configured to determine whether the pupil dilations measured from the wearer's eye are substantially similar; when pupil dilations are different, the first system controller is configured to send the output control signal to said alert mechanism.
[12]
12. Energized ophthalmic lens, according to claim 1, characterized by the fact that said system controller detects a change in pupil size, not in response to a change in the ambient light condition detected by said position sensor system. eyelid, and the pupil size is based on at least one signal from said eye movement sensor system, said system controller sending a control signal to said alert mechanism.
[13]
13. Energized ophthalmic lens, according to claim 1, characterized by the fact that when said system controller detects a stable reading of the accelerometer in a direction indicating that a user is in a prone position after a rapid acceleration in that direction the readings come from said eye movement sensor system, said system controller sends the control signal to said alert mechanism.
[14]
14. Energized ophthalmic lens, according to claim 1, characterized by the fact that the spatial coordinates are in three dimensions.
[15]
15. Energized ophthalmic lens, according to claim 1, characterized by the fact that said motion sensor includes at least one accelerometer; and said system controller compares each signal of said at least one accelerometer against a threshold, and when any signal exceeds the threshold, said system controller sends the
Petition 870170039233, of 06/08/2017, p. 124/437
6/14 control signal for said alert mechanism.
[16]
16. Energized ophthalmic lens, according to claim 1, characterized by the fact that it additionally comprises:
an iris-facing light source in electrical communication with said system controller; and at least one photosensor facing the iris arranged to receive reflected light from the eye, wherein said light originates from said light source, said at least one photosensor is in electrical communication with said system controller ;
a transmitter in electrical communication with said system controller, and said system controller is configured to send a signal from the oximeter to said light source and receive a signal from said at least one photosensor, the received signal of which is transmitted , through said transmitter, to an external device for processing by said system controller.
[17]
17. Energized ophthalmic lens according to claim 1, characterized in that said system controller is configured to use more than one system sensor to confirm any determination by said system controller of a need for the control signal output is sent to said alert mechanism.
[18]
18. Energized ophthalmic lens, characterized by the fact that it comprises:
a contact lens, and a first sensor on said contact lens;
at least a second sensor in said contact lens;
a system controller in electrical communication with said first sensor and said at least one second sensor, said system controller has an associated memory containing a
Petition 870170039233, of 06/08/2017, p. 125/437
7/14 plurality of problem models and at least two sets of registers to store the data received from said sensors, said system controller configured to compare the received sensor data with said plurality of problem models and generate a signal of control when a match occurs, and at least one alert mechanism in electrical communication with said system controller, said alert mechanism is configured to receive the output control signal and capable of at least one of the actions of providing a alert and store data.
[19]
19. Energized ophthalmic lens according to claim 18, characterized in that said first sensor and / or said at least one second sensor are selected from a group consisting of an eyelid position sensor system, a sensor system of eye movement, a biosensor, a bioimpedance sensor, a temperature sensor and a pulse oximeter.
[20]
20. Energized ophthalmic lens, characterized by the fact that it comprises:
a contact lens, a light source facing the iris in said contact lens; at least one photosensor facing the iris arranged to receive reflected light around the eye, in which said light originates from said light source; and a system controller in electrical communication with said light source facing the iris and said at least one photosensor facing the iris, said system controller configured to process at least one signal from said photosensor facing the iris and correlate the processed signal with at least one signal sent to said light source facing the iris.
[21]
21. Energized ophthalmic lens, according to claim Petition 870170039233, of 06/08/2017, p. 126/437
8/14 tion 20, characterized by the fact that it additionally comprises a transmitter in electrical communication with said system controller, and in which said system controller is configured to send, through said transmitter, the correlated signals to an external device for processing.
[22]
22. Energized ophthalmic lens according to claim 20, characterized by the fact that said light source facing the iris and said at least one photosensor facing the iris are spaced apart from each other so that said source of light facing the iris and said at least one photosensor facing the iris are adjacent to opposite edges of said contact lens.
[23]
23. Energized ophthalmic lens according to claim 20, characterized in that said light source facing the iris includes a first light emitter that transmits a light having a wavelength of about 660 nm, and a second light emitter that transmits a light having a wavelength between about 890 nm and about 950 nm.
[24]
24. System for conducting a test protocol on a user of at least one contact lens, said system is characterized by the fact that it comprises:
a device equipped with a processor configured to execute a test protocol, a camera connected to said processor, a display connected to said processor and configured to display images generated by said processor, communication module and at least one energized ophthalmic contact lens having
Petition 870170039233, of 06/08/2017, p. 127/437
9/14 an eye movement sensor system that includes a sensor for determining and tracking the eye position, said eye movement sensor system configured to provide a spatial location of the eye, a system controller cooperatively associated with the sensor, the system controller configured to determine eye movement, based on the spatial location provided by the eye movement sensor system, said system controller is additionally configured to output a control signal based on the determination, and a communication circuit configured to facilitate communication with said communication module of said device during the execution of the test protocol; and said processor executing the test protocol in conjunction with said system controller.
[25]
25. System, according to claim 24, characterized by the fact that said control signal generated by said system controller includes information about the direction of the gaze;
said test protocol correlates the movement of said device performed by an individual while the display is providing directions to an individual with the received eye direction transmitted by said system controller through said communications circuit and said communications module, while if the movement of an individual's head is monitored, when at least one of the actions without correlation or movement of an individual's head occurs, said processor is configured to trigger an alert to be shown on said display; and the directions being generated by said processor, based on instructions executed by said processor.
Petition 870170039233, of 06/08/2017, p. 128/437
10/14
[26]
26. System according to claim 25, characterized by the fact that said device includes an accelerometer electrically connected to said processor, so that said processor is configured to use an output of said accelerometer in conjunction with an output of said camera to determine if the subject's head is stable while said device is moved substantially in a straight line in front of the subject, and said processor is configured to correlate the accelerometer readings of said lens transmitted through said communications circuit and the said communications module with the accelerometer signals from said accelerometer on said device; when a difference between the accelerometer signals after normalization for distance traveled by said device and said lens is greater than a threshold, then said processor is configured to trigger the alert to be shown on said display.
[27]
27. System according to claim 24, characterized in that said lens additionally includes a pupil diameter sensor facing the iris in electrical communication with said system controller, said pupil diameter sensor facing the iris configured to provide a signal that represents the diameter of the pupil;
said device additionally includes a light source controllable by said processor, and said test protocol includes activating said light source by said processor, measuring said pupil diameter by said system controller before and after activating the source of light with said pupil diameter sensor, the transmission of said measurements by said conPetition 870170039233, of 06/08/2017, p. 129/437
11/14 system controller for said processor through said antennas, comparison by said processor of said measurements to determine pupil dilation, and sending by said processor an alert to said display when at least one pupil dilation exceeds a dilation threshold and pupil dilation is less than an undilated threshold.
[28]
28. System according to claim 27, characterized in that said contact lens additionally includes a photodetector in communication with said system controller; and wherein said system controller is configured to use outputs from said photodetector to detect a light level from said light source.
[29]
29. System according to claim 24, characterized in that said lens additionally includes a pupil diameter sensor facing the iris in electrical communication with said system controller, said pupil diameter sensor facing the iris to measure the diameter of the pupil;
said device additionally includes a light source controllable by said processor, and said test protocol includes the display by said processor of instructions on said display that guide said user to look at a bright light, the measurement of said pupil diameter by said system controller before and after activation of the light source with said pupil diameter sensor, the transmission of said measurements by said system controller to said processor through said antennas, the comparison by said processor of said measurements for determine pupil dilation, and the sending by said processor of an alert for said provision 870170039233, of 06/08/2017, p. 130/437
12/14 play when at least one pupil dilation exceeds a dilation threshold and the pupil dilation is less than an undilated threshold.
[30]
30. System according to claim 29, characterized in that said contact lens additionally includes a photodetector in communication with said system controller; and said system controller being configured to use outputs from said photodetector to detect a light level from said light source.
[31]
31. System according to claim 24, characterized by the fact that said sensor includes at least one accelerometer; and said test protocol is triggered by the detection of a possible concussion when said system controller determines that an acceleration of the user's head has exceeded a concussion threshold based on a signal received from said accelerometer.
[32]
32. System according to claim 24, characterized by the fact that said test protocol includes making a lens wearer focus on a stationary object in one location, turning the wearer's head to the right or left while the wearer continues to look at the location, track the user's gaze in relation to the user's head turning speed to determine if the differential is within a predetermined threshold, alert at least one of the user through said alert mechanism and / or transmitting an alert signal to said device to display an alert on said display.
[33]
33. System according to claim 32, characterized by the fact that said eye movement sensor includes at least one
Petition 870170039233, of 06/08/2017, p. 131/437
13/14 accelerometer; and the differential is determined based on a signal from said at least one accelerometer, in which a signal equal to zero is the confirmation of the location tracking on the wall by the user, whereas when a signal is a value other than zero it indicates a user's delay in tracking the location on the wall.
[34]
34. System according to claim 32, characterized by the fact that said test protocol additionally includes storing data on said device from said test protocol for later use in a verification study.
[35]
35. System for conducting a test protocol on a user of at least one contact lens, said system is characterized by the fact that it comprises:
at least one energized ophthalmic contact lens having a pupil diameter sensor facing the iris configured to emit a signal representing the pupil diameter;
at least one photodetector facing forward; an alert mechanism;
a system controller in communication with said iris-facing pupil diameter sensor and said at least one photodetector, the system controller is configured to monitor said iris-facing pupil diameter sensor outputs, monitoring said at least one photodetector facing forward for a detected light that exceeds a brightness threshold, compare the output of the pupil diameter sensor facing the iris before and after detecting light that exceeds the brightness threshold, when the difference between the diameter sensor outputs
Petition 870170039233, of 06/08/2017, p. 132/437
14/14 pupil facing the iris exceeds a dilation threshold or is less than an undilated threshold, send a signal to said alert mechanism.
[36]
36. System, according to claim 35, characterized by the fact that the user is alerted by said alert mechanism in response to the signal from the system controller.
Petition 870170039233, of 06/08/2017, p. 133/437
100Α

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法律状态:
2018-01-02| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

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2020-09-15| B11A| Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing|

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2020-12-01| B11Y| Definitive dismissal acc. article 33 of ipl - extension of time limit for request of examination expired|

优先权:

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申请号 | 申请日 | 专利标题

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US15/179,184|2016-06-10|

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US15/179,184|US20170354326A1|2016-06-10|2016-06-10|Electronic ophthalmic lens with medical monitoring|

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