The subject matter of this disclosure relates to techniques for measuring intraocular pressure in human eyes, using an implantable pressure sensor. Such techniques are useful for treating and/or monitoring progression of eye diseases including glaucoma, but are not limited to use with the treatment of eye disease.
Intraocular pressure (IOP) refers to the pressure of a fluid known as the aqueous humor inside the eye. The pressure is normally regulated by changes in the volume of the aqueous humor, but some individuals suffer from disorders, such as glaucoma, that cause chronic heightened IOP. Over time, heightened IOP can cause damage to the eye's optical nerve, leading to loss of vision. Presently, treatment of glaucoma mainly involves periodically administering pharmaceutical agents to the eye to decrease IOP. These drugs can be delivered, for example, by injection or eye drops. However, effective treatment of glaucoma requires adherence to dosage schedules and a knowledge of the patient's IOP. The more current or recent the measurement is, the more relevant it will be and hence the more effective the resulting treatment can be. The IOP for a given patient can vary significantly based on time of day, exercise, how recently a medication was taken, and other factors. Typically, IOP measurements are performed in a doctor's office and often no more than once or twice per year. These infrequent measurements are less able to account for variation in the patient's IOP, and may become stale due to the length of time between them. This means that any given measurement is subject to uncertainty, so it may take several IOP measurements over time to have confidence in the health of the patient's eye.
Typically, the IOP is measured using a tonometer, which is a device that is outside the eye and thus does not require a sensor within the eye. Contact tonometry is performed in a clinical setting, and the procedure requires numbing of the patient's eye, resulting in both inconvenience and discomfort. Noncontact tonometry involves directing a puff or jet of air towards the patient's eye and measuring the resulting deflection dynamics of the cornea. However, this requires a bulky and power hungry pump arrangement that may not be practical for home use, and is not as accurate as contact tonometry.
A wireless, implantable, continuous IOP monitoring system has been suggested that has a commercial pressure sensing element with digital readout, and a microelectronic chip that supports wireless power/data telemetry and a wired serial communication interface with the pressure sensing element. An on-chip integrated RF coil receives power from near-field RF coupling at 915 MHz, and transmits pressure measurement bits via RF-backscattering to an external reader.
An aspect of the disclosure here is an intraocular pressure, IOP, sensor that, once implanted into an eye of a user, may be powered optically through ambient lighting (e.g., by sunlight, room or office lighting) rather than by a dedicated light source or by any specific action of its user. The IOP sensor includes an implanted intraocular pressure sensing element that is coupled to implant microelectronic circuitry. The intraocular pressure sensing element may be implanted into the cornea or sclera, without piercing into the anterior chamber of the eye. Also implanted into the cornea or sclera may be the implant microelectronic circuitry, which may be implanted into an area of the sclera that is comparable in thickness to the cornea. The implant microelectronic circuitry produces measured pressure data, using the intraocular pressure sensing element. The implant microelectronic circuitry communicates the measured pressure data optically, e.g., via a microscopic light emitting diode (micro LED) that transmits the data out of the eye. In addition to the implanted microelectronic circuitry and the implanted intraocular pressure sensing element, the IOP sensor also includes an implanted photovoltaic element which supplies energy to operate other components of the IOP sensor. The IOP sensor is thus said to have an all optical interface which includes the micro LED and the photovoltaic element, and that enables the use of light to both power the IOP sensor and communicate measured pressure data out of the IOP sensor. The all optical interface enables the IOP sensor to be small, e.g., less than ten cubic millimeters in volume, as compared to an implantable IOP sensor that has an RF data communication antenna. Such a small size reduces interference with operation of the eye and reduces surgical side effects, while the IOP sensors ability to be powered by ambient light alone makes the system as whole, for measuring IOP, easier for the user to use.
For the optical interface to enjoy greater optical transparency, the micro LED and the photovoltaic element can be implanted into the cornea. However, the micro LED and the photovoltaic element could alternatively be implanted into the sclera so long as the higher light scattering characteristics of the sclera are taken into consideration when designing the IOP sensor as a whole. Aspects of the IOP sensor to consider here include power consumption of the implant microelectronic circuitry, energy capacity and size of a battery that temporarily stores the energy produced by the photovoltaic element, and the power output and size of the photovoltaic element. Placing as much the IOP sensor as possible into the sclera could reduce risk of complications for the vision of the user. The fidelity of sensing the intraocular pressure (by the intraocular pressure sensing element) would depend on the implantation depth of the intraocular pressure sensing element and may calibrated after surgery.
The optically transmitted measured pressure data is received by outside-of-the-eye microelectronic circuitry that is integrated into a handheld or portable reader device. The reader device can be held by the user, and when brought close to the user's eye it can receive the optically transmitted measured pressure data. The received measured pressure data may then be further processed or evaluated by the outside-of-the-eye microelectronic circuitry, for purposes of for example informing the user about their intraocular pressure.
The above summary does not include an exhaustive list of all aspects of the present disclosure. It is contemplated that the disclosure includes all systems and methods that can be practiced from all suitable combinations of the various aspects summarized above, as well as those disclosed in the Detailed Description below and particularly pointed out in the Claims section. Such combinations may have particular advantages not specifically recited in the above summary.
Several aspects of the disclosure here are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings, in which like references indicate similar elements. It should be noted that references to “an” or “one” aspect in this disclosure are not necessarily to the same aspect, and they mean at least one. Also, in the interest of conciseness and reducing the total number of figures, a given figure may be used to illustrate the features of more than one aspect of the disclosure, and not all elements in the figure may be required for a given aspect.
Several aspects of the disclosure with reference to the appended drawings are now explained. Whenever the shapes, relative positions and other aspects of the parts described are not explicitly defined, the scope of the invention is not limited only to the parts shown, which are meant merely for the purpose of illustration. Also, while numerous details are set forth, it is understood that some aspects of the disclosure may be practiced without these details. In other instances, well-known circuits, structures, and techniques have not been shown in detail so as not to obscure the understanding of this description.
The IOP sensor 1 includes the following components. An intraocular pressure sensing element 3 is to be implanted into an eye of a user, in the cornea (e.g., as shown in
The implant microelectronic circuitry 4 uses a signal (in the conductive coupling) from the intraocular pressure sensing element 3 to produce measured pressure data. The signal may be an analog signal (e.g., that is input to a sensing amplifier which is part of the implant microelectronic circuitry 4), or it may be a digital signal (e.g., the sensing amplifier and a digitizer are part of the intraocular pressure sensing element 3.) The implant microelectronic circuitry 4 drives a microscopic light emitting diode, micro LED 6, the latter also being implanted in the eye of the user for example within the same housing or package as the implanted microelectronic circuitry 4. The micro LED 6 is thus optically transmitting the measured pressure data, for communication with outside of the eye. The micro LED 6 may transmit light at a wavelength that is in the visible region or in the near infrared region. The micro LED 6 may be no more than 0.2 millimeters squared in area. The micro LED 6 may be one of several micro LEDs that are implanted into the eye and that are driven with the measured pressure data for communication with outside of the eye, e.g., a pair of micro LEDs that are operated in a different data transmission mode to improve signal to noise ratio particularly when the ambient light is changing.
The IOP sensor 1 also includes a photovoltaic element 7 which is also implanted into the eye, and may be within the same housing or package as the implant microelectronic circuitry 4. The photovoltaic element 7 is configured to convert incident ambient light, e.g., solar, into energy that it supplies to operate the implant microelectronic circuitry 4 and the microscopic LED 6. The photovoltaic element 7 may be configured to continuously provide its converted energy to be stored temporarily within, or recharge, a battery 8. The battery 8 is also implanted in the eye, for example within the same housing or package as the implant microelectronic circuitry 4 or the photovoltaic element 7, and supplies its stored energy to power the components of the IOP sensor 1. Note, the term “battery” is used generically here, to refer to any type of rechargeable solid state device (e.g., a solid state battery) or other electricity storage device that can be charged and recharged by the photovoltaic element 7. In one aspect, the photovoltaic element 7 is no more than 5 square millimeters in area, supporting a total power consumption by the IOP sensor 1 of a few tens of nano Watts on average. In one aspect, the photovoltaic element 7 should be tuned to also work (have a reasonable level of photovoltaic output power per area) with solely indoor ambient lighting, such as in a warehouse, office space, or retail space. The photovoltaic element 7 and the micro LED 6 should be placed in a region of the eye that that has sufficient optical transparency to the outside world for them to operate as intended, for example in the cornea as shown in
In one aspect, there may be a single package that contains the battery 8, the photovoltaic element 7, the implant microelectronic circuitry 4 and the micro LED 6, and such a package may be less than 10 cubic millimeters in volume. This size may be largely dictated by the size of the battery 8 and the photovoltaic element 7.
In one aspect, the implant microelectronic circuitry 4 may include an application specific integrated circuit, ASIC, that has a watchdog timer that triggers the taking of measurements of the IOP (or producing measured pressure data) at intervals programmed into the watchdog timer. These intervals may be regular (e.g., one measurement every fifteen minutes) or they may be irregular (e.g., one measurement every half hour, and once a day a burst of measurements is taken every five hundred milliseconds for ten seconds.) Each measurement may be stored in memory of the implant microelectronic circuitry 4 (e.g., in a static random access memory module) along with a timestamp for the measurement, until it is time to transmit the measurement (as produced measured pressure data) out of the IOP sensor 1. The capacity of the battery 8 should be selected to provide enough energy for taking such measurements even when the user's eye (in which the IOP sensor 1 has been implanted) has not been exposed to light that can recharge the battery 8 (e.g., solar light outside), for a reasonable amount of time. This reasonable amount of time, during which only the energy stored in the battery 8 will power such measurements, is between seven hours (which is close to the average recommended hours of sleep per day for an adult) and thirty-six hours, e.g., twenty-four hours. In one aspect, this allows the IOP sensor 1 to take measurements at night time or when the user is asleep.
In one aspect, the outside-the-eye microelectronic circuitry transmits an optical interrogation signal that is detected by the implant microelectronic circuitry using the microscopic LED (operating in reverse bias), the photovoltaic element, or a separate photodetector element. In response, the implant microelectronic circuitry becomes aware that the reader device 2 is within range to receive from the IOP sensor 1, and therefore drives the micro LED with the measured pressure data thereby optically transmitting the measured pressure data for communication with the outside-of the-eye microelectronic circuitry.
In one aspect, the transmit power of the micro LED is adjusted so that a maximum amount of measured pressure data can be transmitted or uploaded, with the available energy in the battery 8. In another aspect, the optical receiver circuitry of the outside-the-eye microelectronic circuitry is optimized so as to maximize signal to noise ratio (e.g., via spectral filtering.) Also, error correction bits may be included in the transmitted, measured pressure data, which the outside-the-eye microelectronic circuitry uses to ensure that it is receiving the pressure data correctly. Bi-directional communication between the outside-the-eye microelectronic circuitry and the implant microelectronic circuitry may help further ensure that IOP sensor 1 aware of the fact that the measured pressure data has been uploaded into the reader device 2. In a further aspect, the memory within the IOP sensor 1 has sufficient data storage capacity to store or log all measurements that are taken between measured pressure data upload times.
In yet a further aspect, the implant microelectronic circuitry operates predominantly, e.g., more than 99% of the time, in a background mode of operation in which it produces no measured pressure data and in which it transmits no measured pressure data. This helps reduce its power consumption, which in turns reduces the size of the photovoltaic element and the battery.
In one aspect, the IOP sensor 1 may be configured to be used as an on-demand device: in a first phase of an interaction between the reader device 2 and the IOP sensor 1, the reader device 2 provides power to the IOP sensor 1; and then in a second phase the IOP sensor 1 takes the measurements and transmits the measured pressure data back to the reader device 2.
While certain aspects have been described and shown in the accompanying drawings, it is to be understood that such are merely illustrative of and not restrictive on the broad invention, and that the invention is not limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those of ordinary skill in the art. For example, while
This nonprovisional patent application claims the benefit of the earlier filing dates of U.S. provisional patent applications 63/306,000 and 63/306,002 both filed 2 Feb. 2022.
Number | Date | Country | |
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63306000 | Feb 2022 | US | |
63306002 | Feb 2022 | US |