The present invention generally relates to medical devices and specifically to non-contact home-tonometry system for measuring intraocular pressure.
Glaucoma is a disease that affects millions of people across the globe, about 3 million Americans suffer from this disease and 12 million more are at a risk of developing the disease. It is said to be the second leading cause of blindness and is correlated with an elevated intraocular pressure (IOP). In the standard model, the rise in intraocular pressure results when there is excessive aqueous humour in the anterior chamber of the eye because of the imbalance between the quantity of fluid secreted from the ciliary body and that drained through the trabecular meshwork. Since the chamber cannot increase in size, the fluid presses against the retina walls, compressing and damaging the cells along the optic nerve, causing the cells to die which leads to loss of vision.
A number of different tonometers have been developed over the years to measure IOP. Most of the existing tonometers, however, can only be used in clinical settings by health care professionals, such as ophthalmologists or optometrists. But, the IOP is not a constant value but fluctuates throughout the day with a 24-hour periodicity of circadian rhythms and hence necessitates measurement outside typical health care professional office hours. Accordingly, there is still a need for patient-operated tonometers that are easy to use and provide reliable IOP measurements.
Three basic principles are known for measuring the intraocular pressure, namely, impression tonometry, applanation tonometry and noncontact tonometry. The impression tonometer measures the depth of the indentability of the cornea caused by a metal stamp loaded with a known weight. For the same weight the indentability is inversely proportional to the intraocular pressure, that is the greater the indentability is, the lower is the intraocular pressure and conversely. A disadvantage with impression tonometry is that the placement of the tonometer and the impression of the metal stamp additionally increase the intraocular pressure so that the measured pressure does not correspond exactly to the actual intraocular pressure. Furthermore, the placement of the stamp on the cornea of the patient's eye is relatively stressful for the patients.
Furthermore, so-called applanation tonometers are also known for measuring the intraocular pressure, its measurement being based on application of the applanation principle. The applanation principle starts from lngbert's law which states that the pressure in a spherical container filled with liquid corresponds to the counter-pressure which flattens a certain surface of this sphere. The intraocular pressure can be measured on the basis of this law in two different ways. According to a first alternative, a tonometer with constant weight can be used and the flattened surface can be measured. According to an alternative method of measurement, the force required to flatten a known surface of constant size is used A Perkins applanation tonometer is known, which consists of a plastic cylinder whose lower planar end is provided with a gradation. A magnifying glass is located at the upper end. After instilling a fluorescent liquid into the conjunctival sac, the diameter of the applanated corneal surface can be determined by optical reading off on the gradation scale. In this case, the intraocular pressure is determined by means of a constant force.
In addition, an applanation tonometer operating on the principle of an applanated surface of constant size is known. In this case, the cornea is flattened using the quadrilateral base of a glass prism. The intraocular pressure is measured by intensifying the pressure of the prism on the eye until the flattened circular region of the cornea is at the same level as the four sides of the prism base. A disadvantage with applanation tonometers again is that as a result of the deformation of the cornea by means of an actuating element, considerable stress is produced for the patients.
So-called noncontact tonometers were developed to avoid this stressing produced by contact with a deforming tool. In these noncontact tonometers actuating devices are provided for deforming the cornea with which the cornea is deformed free from contact. For this purpose, a puff of compressed air is produced for example and directed onto the cornea. In known noncontact tonometers air puffs are directed onto the eye in the direction of the optic axis whereby the cornea is increasingly flattened and finally indented. To measure the deformation of the cornea, an obliquely incident bundle of parallel light rays is directed onto the cornea and the light reflected by the cornea is measured as a measurement signal. For this purpose, the reflected light can be intercepted by a light sensor, for example, where the light intensity measured by the light sensor varies as a function of the applanation of the cornea caused by the air flow.
A disadvantage in all known methods of measurement is that when measuring the intraocular pressure, the counter-pressure caused by the elastic deformation of the cornea is not taken into account. This is because the cornea itself is stretched over the vitreous body in the fashion of an elastic membrane so that during the measurement of the intraocular pressure a certain amount of force is required for its deformation which is included in the measurement results in a falsifying manner. This falsification is of a different magnitude in different patients since the properties of the cornea, especially its thickness and elasticity, vary within certain limits.
According to an aspect of the present invention there is provided an ophthalmological analysis system, comprising: an air-puff generating device configured to apply an air-puff to a user's at least one eye; and at least one sensors board configured to detect and record deformation of a cornea of the user during the air-puff; wherein the detection is a three dimensional (3D) active stereo detection; the sensors board further configured to find two applanation points and hysteresis of the cornea and to calculate intraocular pressure in the user's at least one eye accordingly.
The air-puff generating device may comprise: a piston, activated by automatic drive means, slidably received by a cylinder housing and axially driven relative to the cylinder housing to compress air within a compression chamber defined by the cylinder housing; and an air discharge tube connected with the compression chamber for directing the air-puff along an optical axis towards the cornea.
The automatic drive means may comprise one of a linear motor, a rotary solenoid and a voice coil.
The air-puff generating device may further comprise a pressure sensor mounted inside the compression chamber.
The air-puff may be directed towards the cornea via an air-puff nozzle; wherein the air-puff generating device may further comprise a pressure sensor mounted inside the air-puff nozzle.
The air-puff generating device may comprise: a cylinder containing compressed air; an air chamber connected with the cylinder via an electric valve; and an air-puff nozzle connected with the air chamber via an electrical air regulator and an electrical valve.
The air-puff generating device may further comprise a pressure sensor mounted inside the air chamber.
The air-puff generating device may further comprise a pressure sensor mounted inside the air-puff nozzle; the pressure sensor may be configured to measure the air-puff pressure over time.
The system may further comprise an eye drop dispensing sub system comprising: an eye drop reservoir connected with an electric dosage pump; and a nozzle connected with the electric dosage pump; the eye drop dispensing sub system may be configured to perform an eye drop cycle thereby allowing an accurate dosage and placement of at least one drop into the user's at least one eye.
The eye drop reservoir may be configured to dispense the eye drops as one of spray and aerosol.
The at least one sensors board may comprise: a line-scan sensor; wherein the line-scan sensor is divided into two viewing angles thereby allowing calculation of medial displacement over time; an optical integrated lenses array mounted on top of the line-scan sensor; a pattern-projector; an air-puff nozzle; a multi-spectral Light Emitting Diode (LED); and a video camera.
The optical integrated lenses array may comprise four fixed mirrors.
The optical integrated lenses array may comprise two fixed mirrors and two movable mirrors.
According to another aspect of the present invention there is provided a method of calculating intraocular pressure, comprising: applying an air-puff to a user's at least one eye; detecting and recording, using a three dimensional (3D) active stereo detection, deformation of a cornea of the user during the air-puff by a line-scan sensor divided into two viewing angles thereby allowing calculation of medial displacement over time; finding two applanation points of the cornea; and calculating intraocular pressure in the user's at least one eye accordingly.
The applying an air-puff step may comprise: activating, by automatic drive means, a piston inside a compression chamber thereby discharging the air-puff along an optical axis towards a cornea of the user.
The automatic drive means may comprise one of a linear motor, a rotary solenoid and a voice coil.
The applying an air-puff step may comprise releasing a compressed air from a cylinder.
The method may further comprise: dispensing at least one eye drop into the user's at least one eye.
For better understanding of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings.
With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the accompanying drawings:
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is applicable to other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
The present invention provides an ophthalmological analysis system and method for measuring the Intra Ocular Pressure (IOP) of the eye.
The system of the present invention can easily be used outside the health professional's office, is non-invasive and measures the IOP using an optical system, so the need for anesthesia and the risk of infection are completely eliminated. With the system of the present invention, measurement of IOP can be done within fractions of a second, which eliminates the prolonged time required, in other devices, for positioning the patient before measurements can be done. Furthermore, the system of the present invention may measure both eyes simultaneously.
The measurement can be done in various positions, e.g., sitting, recumbence, lying down, etc. The accuracy of measurements with the disclosed system is not dependent on technique or the expertise of the operator. Accordingly, the system of the present invention is appropriate for use in non-clinical settings such as at a patient's home or in places across the globe where an ophthalmologic service is not readily available.
However, the system of the present invention can be used in clinical settings as well, and the invention as presently claimed should not be construed as limited to self-measurement devices or methods of self-measurement.
It is thus an objective of the present invention to provide a Non-Contact Tonometer (NCT) capable of measuring true IOP.
These and other objectives are achieved generally by a method of measuring intraocular pressure comprising the steps of:
A) Directing a air pulse at a cornea to cause reversible deformation of the cornea from an original state of convexity through a first state of applanation to a state of concavity, and back through a second state of applanation to the state of convexity;
B) Acquiring a first pressure value (P1) associated with the air pulse at the time of the first state of applanation and a second pressure value (P2) associated with the air pulse at the time of the second state of applanation; and
C) Calculating an intraocular pressure value using a predetermined function of the first pressure value (P1) and the second pressure value (P2), where the function was empirically derived to minimize cornea-related influence on the intraocular pressure value. According to embodiment of the present invention, the empirically derived function may be:
IOP=K1(F1×P1+P2)+K2
Where—F1, K1 and K2 are constants.
Both pressure values (P1) and (P2) are determined using image processing algorithms that find the two applanation points. The image processing algorithms are based on calculation of the cornea curvature index by using a high speed three-dimensional stereo camera images. The three-dimensional stereo camera optical arrangement may be passive or active, by using a pattern projector. The three-dimensional stereo camera optical arrangement uses a single line-sensor optically divided into two viewing angles, left and right, with a pattern projector. The algorithms analyze the pattern images from the two stereoscopic angles, left and right, and calculate the medial displacement over time. The optical system includes, among others, the three-dimensional stereo camera (line-scan sensor), a video camera, multispectral LEDs (visible and non-visible) and a pattern projector. The optical system is a self-calibrated system, with high field of view depth. According to embodiments of the present invention, the IOP system comprises two identical optical systems, one for each eye, left and right. The two optical systems have a mechanical apparatus for optimizing the distance between the two, left and right, corneas. Alternatively, the IOP system may comprise one optical system. In such a configuration, the system may further comprise a mechanical sub system for moving the optical system from one eye to the other.
The present invention includes an electrical subsystem with a board such as, for example, a System on Module (SOM) board that activates and controls the optical system, the air-puff compressor, and other components. In addition, the board is used for the image processing algorithms and IOP algorithms. Furthermore, the board communicates wirely or wirelessly with an external device such as a PC, smartphone, etc. running an IOP application.
It will be appreciated that the head-mount unit 110 is not limited to include two optical sensors boards. Alternatively, the unit 110 may include one optical sensors board which may move from one eye to the other for performing the process.
Piston 1110 is pushed very rapidly from a starting position in order to generate a short air puff and moves back in a reciprocal direction to its starting position.
According to embodiments of the present invention, each nozzle, 1145A or 11458, may be closed in order to direct the air-puff to one of the eyes.
According to embodiments of the present invention, the air chamber 1215 may be connected with another air-puff nozzle (not shown) for the other eye.
A shows the cornea in its original and natural convex state.
B shows the cornea in a first state of applanation as the cornea is pushed inwardly by the air puff.
C shows the cornea in a concave state as the air puff pushes the corneal tissue beyond flat state shown in B.
D shows the cornea in a second state of applanation as the cornea returns.
E shows the cornea returns to its original and natural convex state.
Point P2 is related to the cornea in a first state of applanation as the cornea is pushed inwardly by the air puff. Point P3 is related to the cornea in a concave state. Point P4 is related to the second state of applanation. Point P5 is related to the cornea in its original and natural convex state. The two applanation points P2 and P4 are measured at two different pressures, this corneal hysteresis associated with the IOP measurement is found by calculating a pressure difference between the inward applanation pressure P2 and the outward applanation pressure P4.
As mentioned above in
It will be appreciated that if the eye drop dispensing process is performed sequentially after the process described in conjunction with
The user application may show the measured IOP level of the last measurement and an accumulation graph of all the measures over time. In addition, the application may comprise a system built-in test (BIT) for checking initial condition(s) before measurement, user's personal information, user ophthalmologist, etc. This application is connected to a database that collects all the data from all users.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined by the appended claims and includes combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description.
This patent application claims priority from and is related to U.S. Provisional Patent Application Ser. No. 62641429, filed 12 Mar. 2018, this U.S. Provisional Patent Application incorporated by reference in its entirety herein.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2019/050019 | 1/2/2019 | WO | 00 |
Number | Date | Country | |
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62641429 | Mar 2018 | US |