JP2022526645A - Intraocular pressure monitoring device and how to use it - Google Patents

Abstract

Various devices, systems, and methods for measuring intraocular pressure in the eye using stress or pressure sensors placed on or in the eye are described herein. In one embodiment, the system for measuring the intraocular pressure of the eye is a deformable sensor suitable for placement on the eye, the stress sensor having a biocompatible body and a photoelastic sensor. , A deformable sensor and a rotating light analysis measuring device, wherein the rotating light analysis measuring device has a light source and a plurality of polarizing filters and is capable of producing polarized light. It is equipped with a mobile computer device that has a camera.

Description

(Mutual reference of related applications)
The present application is a US provisional patent application No. 62 filed on April 10, 2019, entitled "Intraocular Pressure Monitoring Method and Devices Using the Same," which is incorporated herein by reference in its contents. / 832, 151 (Patent Attorney Reference No. 48675-708.101) claims priority.

The present disclosure relates to methods, systems, and devices for intraocular pressure (IOP) sensing.

(background)
Photoelasticity describes a change in the optical properties of a material under mechanical deformation. It is a property of all dielectric media and is often used to experimentally determine the stress distribution within a material, giving an image of the stress distribution around the discontinuity within the material.

Systems, devices, and methods for intraocular pressure sensing using photoelastic materials in combination with other materials are described herein. The process involves the placement of the sensor on or in the eye, using either contact lenses or intraocular lenses, respectively. The lens comprises a sensor made of a photoelastic material. As the internal pressure of the eye changes, the radius of curvature of the eye changes, which can create a stress effect on the contact lens sensor. Alternatively, for an implanted intraocular lens, pressure changes can be measured by directly measuring the pressure on the intraocular lens. Pressure and stress changes cause the photoelastic material to change shape and alter the transmission of reflected light. This modified reflectance can be captured, analyzed and correlated with known changes in IOP to produce accurate measurements of eye IOP.

In some embodiments, there may be a device for conforming to the surface contour of the eye. The device is made of biocompatible material and has a body shaped to resemble a contact lens and a stress sensor embedded within the body. The stress sensor may have an annular ring with a central opening and a plurality of secondary openings arranged around the central opening, the plurality of secondary openings defining multiple struts, and the annular ring being photoelastic. Can be made from material. The shape of the annular ring, the opening, and the plurality of secondary openings defines the occupied area of the annular ring. The reflector material can be layered underneath the annular ring and the reflector material has substantially the same occupied area as the annular ring. The stanchions of the annular ring will bend in response to changes in the surface contour of the eye.

In some embodiments, there may be a photoelastic intraocular lens (PEIOL) for measuring intraocular pressure (IOP) in the eye, the intraocular lens having a body made of biocompatible elastoma material and body. Can be configured to fit in the eye. The PEIOL may have a first support leg, which extends radially from the body. PEIOL has a photoelastic layer with a central opening and a plurality of secondary openings arranged in a ring around the central opening, the secondary opening defining a plurality of struts. The stanchions act as multiple stress concentration features. The photoelastic layer can be embedded within the body. The reflector layer may have an occupied area that substantially matches the photoelastic layer. The reflector layer may be adjacent to the photoelastic layer. PEIOL may also have a first gas-filled cavity adjacent to either the photoelastic layer or the reflector layer. Changes in IOP in the eye exert pressure on the body, then deformation of the photoelastic layer produces optical results.

In some embodiments, there may be an optical rotation analysis measurement device for reading optical data and generating IOP data. The optical rotation analysis measurement device has a main body and a circuit contained in the main body, the circuit having a microcontroller, an analyzer, and an interface connector. The optical rotation analysis measurement device is a light source that electronically communicates with a circuit, and the light source has a light source having variables controlled through the circuit. Polarizers with retarders can also be present, which can regulate the output of the light source to produce a particular polarization. The camera may continuously capture images from a PECL or PEIOL device. The optical rotation analysis measurement device can evaluate the image captured by the camera and calculate the IOP reading for the eye.

In some embodiments, there are systems for measuring intraocular pressure in the eye. The system may have a deformable sensor suitable for installation on the eye, the deformable sensor may have a biocompatible body and a photoelastic sensor. The system may also have a light source, which is capable of producing a variety of different wavelengths and pulses of light. Image sensors may also exist, and the image sensor is capable of capturing the light reflected from the photoelastic sensor in the form of image data. The system may have a mobile computer device to analyze the image data and correlate the image data with a set of intraocular pressure levels.

In some embodiments, there are processes that determine the intraocular pressure of the eye. The process is to use a camera to collect multiple images of a PECL or PEIOL device under first and second lighting conditions, and to align multiple images using a computer. To align multiple images, remove geometric drift from multiple images, filter multiple images using a computer, and use a computer to within multiple images. It involves identifying the location of multiple stress concentration areas and analyzing the stress concentration areas using a computer to determine the IOP value.

To easily identify the discussion of any particular element or action, the most significant digit or multiple most significant digits in a reference number refers to the figure number in which the element was first introduced.

FIG. 1 illustrates item 100 according to one embodiment.

FIG. 2 illustrates a cross-sectional view of the PECL 200 according to an embodiment.

FIG. 3 illustrates an alternative cross-sectional view of the PECL 300 according to an embodiment.

FIG. 4 illustrates a sample cross-sectional view of PECL 400 according to an embodiment.

FIG. 5 illustrates a comparison of sample stress loads calculated under two different loads 500 according to one embodiment.

FIG. 6 illustrates a stress sensor 600 according to an embodiment.

FIG. 7 illustrates a stress sensor 700 according to an embodiment.

FIG. 8 illustrates light measurements reflected from sensors installed on an eye model at two different pressure loads 800 according to one embodiment.

FIG. 9 illustrates a graph 900 of light intensity and load measured between holes according to an embodiment.

FIG. 10 illustrates a sample optical rotation analysis and measurement device 1000 according to an embodiment.

FIG. 11 illustrates a sample optical rotation analysis and measurement device 1100 according to an embodiment.

FIG. 12 illustrates a sample optical rotation analysis and measurement device 1200 according to an embodiment.

FIG. 13 illustrates an optical head connected to a mobile device 1300 according to an embodiment.

FIG. 14 illustrates a functional diagram of the system 1400 according to an embodiment.

FIG. 15 illustrates a flow chart of the analysis process 1500 according to an embodiment.

FIG. 16 illustrates a photoelastic intraocular lens (PEIOL) 1600 according to an embodiment.

FIG. 17 illustrates a cross-sectional view of the PEIOL 1700 according to an embodiment.

FIG. 18 illustrates a cross-sectional view of PEIOL 1800 according to an embodiment.

All illustrations in the drawings are for purposes of illustrating selected versions of the various embodiments of the present disclosure and are not intended to limit the scope of the invention.

Systems, devices, and methods associated with measuring IOP (intraocular pressure) in the eye are described herein. The techniques described herein relate to measuring methods, associated devices, and small readout systems that allow quantitative determination of intraocular pressure through the use of wearable or implantable lenses.

Here, with reference to FIG. 1, a cross-sectional view (FIG. 1A) and a plan view (FIG. 1B) structure of item 100 of a photoelastic contact lens (PECL) are shown. In some embodiments, there are devices for shaping to fit the surface contour of the eye. The device is made of biocompatible material and has a body shaped to resemble a contact lens. There may also be stress sensors embedded in the body. The stress sensor can be an annular ring with a central opening and a plurality of secondary openings arranged around the central opening. The secondary opening can define several stanchions. The annular ring can be made from a photoelastic material. The shape of the annular ring, the opening, and the secondary opening may define the occupied area of the annular ring. The reflector material can be layered under an annular ring of photoelastic material. The reflective layer may have an occupied area that substantially matches the occupied area of the annular ring. The struts of the annular ring can bend in response to changes in the surface contour of the eye. Bending of the annular ring will result in image reflectance with deviations that can be measured and used to quantify changes in intraocular pressure in the eye.

In certain embodiments, the cross-sectional view of PECL shown in FIG. 1A represents a cross-sectional view of the light beam shown in FIG. 1B. The horizontal rays represented by the dark dashed line illustrate the cross-sectional view on the right side of FIG. 1A. The right side of FIG. 1A illustrates a cross section through the secondary opening 118 with a corresponding cutout 110. The cutout 110 can be filled with a soft material such as hydrogel. In another embodiment, the left side of FIG. 1A illustrates a ray of smaller dotted line with alternating chain lines and dots. Here, the cross-sectional view passes through the stanchion 120, shows the solid length of the reflector layer 104, and is not accompanied by a corresponding cutout 110 above it.

The use of the terms "substantially" or "generally" refers to the degree of flexibility in the terminology used herein. "Substantially" means that the components are referred to as having a margin of up to +/- 20% with respect to the dimensions discussed, the dimensions being height, weight, age, thickness. , Or any other quantifiable parameter. In some embodiments, the reflector layer and the photoelastic layer can be substantially the same. That is, the two occupied areas can fluctuate up to +/- 20% from each other. In some embodiments, the reflector layer can be up to about 20% larger than the photoelastic layer. In some embodiments, the reflector layer can be up to about 20% smaller than the photoelastic layer. In some embodiments, the photoelastic layer and the reflector layer may have matching occupied areas. In some embodiments, the precise matching of the photoelastic layer and the reflector layer may not be important. There may be deviations in the coverage of one with respect to the other. In general, both may have an open major opening so as not to interfere with the patient's vision. In some embodiments, the device may have similar or same overlapping secondary openings. In some embodiments, the degree of non-overlapping areas of either the reflector layer 104 and the photoelastic layer 106 can be compensated for in the process of determining the stress that the sensor 114 can experience. In some embodiments, the degree of non-overlap may not affect sensor 114 performance.

PECL (photoelastic contact lens) can be a multilayer device (item 100) with a base layer 102, a reflector layer 104, a photoelastic layer 106, and an upper layer 108. The upper layer 108 can be made from hydrogel for improved biocompatibility. In some embodiments, the base layer 102 and / or the superlayer 108 itself can be a multilayer structure made of two or more different materials. In some embodiments, the multilayer upper layer may have a hydrogel layer for user comfort. In some embodiments, any surface that may come into contact with the patient's eye or eyelids (such as the base layer or upper layer) has a hydrogel coating and may promote comfort in use. PECL can be molded with a radius to match the curvature of the eye, which can be human, animal, or artificial. The photoelastic layer 106 may have one or more cutouts or recesses. The cutout may match the general position of the secondary opening 118 of the reflector layer 104. Thus, when viewed separately, the reflector layer 104 and the photoelastic layer 106 may have similar occupied areas that are substantially matched when one is placed on top of the other. As an example, imagine a cut-out paper snowflake as an occupied area for two layers (reflector and photoelasticity), and when the two paper snowflakes are placed on top of each other, the shape of the cutout and The orientations can substantially match each other. The reflector layer 104 is porous and may allow air to pass through the reflector layer 104. In some embodiments, the reflector layer 104 may have nanopores. In some embodiments, the pores can be smaller or larger. In some embodiments, the size of the pores can act as a filter and prevent bundles of particles from entering the sensor.

In some embodiments, the various materials used to make PECL can be biocompatible materials. The exemplary eye 112 is shown with the pupil and cornea displayed under PECL. The eye is shown for illustrative purposes only and does not represent an element of the technical material described herein. The sensor 114 may appear to be placed above the eyeball, and the central opening 116 (the central opening of the sensor) is positioned so as not to cover the pupil. The reflector layer 104 and the corresponding photoelastic layer may surround the central opening 116. It should be noted that the reflector layer 104 is opaque or partially opaque to visible light, has reflective properties, and can reflect light that can be transmitted through the photoelastic layer 106. Therefore, the light may pass through the photoelastic layer 106, be reflected from the reflector layer 104, and pass through the photoelastic layer a second time prior to being captured by the image sensor. The base layer 102, the photoelastic layer 106, and the superlayer 108 may be substantially transparent to visible light.

In some embodiments, the base layer 102 can be a transparent biocompatible material. In some embodiments, the transparent biocompatible material can be an elastomeric material. Examples of such materials include silicone, polydimethylsiloxane (PDMS), or other clear and flexible polymers, silicone hydrogels, or hydrogels. In some embodiments, other materials used to make contact lenses, including hard contact lenses made of harder plastic or glass material, may also be used. In some embodiments, the photoelastic layer can be a UV curable epoxy.

In some embodiments, the thin material with reflective properties can serve as the reflector layer 104. The thin material can be a metal or metallized material, or a composite material with suitable reflector properties. In some embodiments, the reflector layer 104 can be made from platinum. The reflector layer 104 can be machined or printed into a particular shape as described herein and have a thickness of about 5 nm or more.

In some embodiments, the sensor can be 2 μm to 1,000 μm thick. In some embodiments, the sensor can be between 75 μm and 500 μm. In some embodiments, the sensor can be 100 μm to 250 μm.

In some embodiments, the reflector layer 104 may have a patterned shape. The patterned shape may allow a central secondary opening 118, such as for a person to see through it, and light may pass through the central secondary opening 118 with minimal interference. The reflector layer 104 may have a plurality of other secondary openings 118, which may increase the flexibility of the reflector layer 104. In some embodiments, the reflector layer 104 can be shaped like a ring, with multiple secondary openings 118 cut into the ring so that the ring is visible to humans or animals from it. It has a central opening 116 for the purpose and one or more smaller secondary openings 118. As a metaphor, the reflector layer 104 can resemble a rotary telephone dial without a center, and the reflector layer 104 has secondary openings 118 spaced along the entire perimeter. In some embodiments, the secondary openings 118 may be spaced so that there may be a wider amount of reflector layer 104 than that shown between the secondary openings 118. In some embodiments, the secondary openings 118 can be grouped in symmetrical or asymmetric groups along the perimeter of the reflector layer 104. In some embodiments, the material between each secondary opening 118 may form a strut 120 or other connector between the secondary openings 118. These struts 120 may be thin enough to be flexible under loads such as changes in the IOP of the eye. The strut 120 may concentrate the stress load of the circular portion of PECL into the strut 120 because there is an overall less material for distributing the stress in the presence of the secondary opening 118. Therefore, each secondary opening 118 may help increase the stress load experienced by the strut 120 as compared to PECL without a secondary opening.

In some embodiments, the cutout placed with the PECL ring can be circular. In some embodiments, the cutout can be oval or oval. In some embodiments, the cutouts can be uniform cutouts, or they can vary individually. In some embodiments, alternating cutout designs may exist.

In some embodiments, the reflector layer 104 may be sandwiched between the base layer 102 and the photoelastic layer 106. The photoelastic layer 106 may have a plurality of cutouts 110 that may correspond to the location of the secondary opening 118. The matching position of the cutout 110 and the secondary opening 118 in the photoelastic layer 106 may allow PECL to exhibit a strain-related response at the position of the maximized concentrated stress. The various cutouts 110 may be filled with hydrogel when the upper layer 108 can be placed on top of the assembly. In some embodiments, the cutout 110 may be filled with different materials having properties similar to hydrogel.

In some embodiments, the PECL 200 may include a cavity 208 that may be located above the reflector layer 206, as shown in FIG. The cavity 208 can be of any shape and size with respect to the reflector layer 206 and / or the strut. The cavity 208 can be formed or cut into the photoelastic layer 204. In some embodiments, the cavity 208 may be cut into the base layer 202 such that the cavity is below the reflector layer 206. The cavity 208 may be air-filled or filled with a special gas, gas mixture, or liquid material. In some embodiments, the cavity 208 may amplify the in-plane stress in the base layer 202 in the presence of changes to the corneal radius due to changes in the intraocular pressure of the eye.

In some embodiments, the PECL 300 may have a base layer 310, a photoelastic layer 308, and a hydrogel layer 306, as described above. The reflector 302 may be positioned above the cavity 304 such that the gas-filled cavity 304 may be below the reflector 302. In some embodiments, both the cavity 304 and the reflector 302 can be incorporated within the photoelastic layer 308. In some embodiments, the cavity 304 may be incorporated into the base layer 310.

A cross-sectional view of a portion of the layers within the PECL device 400 according to the embodiment is shown. Referring now to FIG. 4, the photoelastic contact lens may have an upper elastomer layer 402 and a bottom elastomer layer 404. The reflector 412 can separate the two layers, or the two layers can be formed directly on top of the other. In certain embodiments, the upper elastomer layer 402 may have one or more different stress concentration feature holes 406 that separate the thick photoelastic layer 408 from the thin photoelastic layer 410. In some embodiments, the thick and thin photoelastic layers can alternate. In some embodiments, the thick photoelastic layer 408 may be adjacent to another thick photoelastic layer 408 (not shown), or the thin photoelastic layer 410 is adjacent to another thin photoelastic layer 410. Can be. Modifications of the thick or thin photoelastic layer can be used in different patients and different IOP readings can be expected. In some embodiments, some subjects that may benefit from the present disclosure may not be human, and the ocular properties maximize effectiveness with the use of thin and thick photoelastic layers. Therefore, it may be such that a correction of position, orientation, or frequency may be requested. In some embodiments, the patient may suffer from other disorders that may affect his eye or his vision, which requires modifications to the structure and design of the sensors described herein.

In some embodiments, the photoelastic region may have variable thickness at different locations along the cross section. The advantage of such non-uniform thickness is that it may have different overall polarization rotations in different regions, thereby allowing the use of one thickness as a reference region. Such self-referenced measurements may have the advantage of eliminating reflected signals from the front surface of PECL and providing more accurate measurements. In some embodiments, holes between different regions can be eliminated and alternating high and low thickness regions can be stacked along the device. The advantage of such an arrangement can be the elimination of contrast in the reflected light in the absence of distortion, and the appearance of contrast only in the presence of distortion due to IOP changes. Such self-referenced optical measurements also eliminate non-distortion-related optical reflections, allowing for more accurate remote optical measurements.

In some embodiments, the aperture cutout 504 within the reflector layer 508 can have a substantially square shape, as shown in FIG. The partially assembled PECL 500 may have a base layer 502 and a reflector layer 508. The reflector layer 508 may have an open cutout 504 in the shape of a square. The central opening 510 can be large enough that the reflector layer 508 does not interfere with the visual field of the eye. The boundaries of the central opening 510 need not be uniform or circular, as shown. In some embodiments, the stanchions 512 may be connected at intersections. The strut intersection 506 can serve as a stress concentration point. The image on the left side of FIG. 5 illustrates the stress distribution within the thinner shaded area, which can generally be seen to be concentrated within the strut intersection 506. The corners of the square cutout 504 represent the triangular area of the reflector layer 508. The stress concentration points are between the triangles and when a pressure of about 15 mmHg is applied to the base layer 502, the stress is amplified to about 10 MPa.

In some embodiments, the stress sensor (photoelastic layer and reflector layer) can take various forms. In certain embodiments, the reflector layer may have a substantially flat donut shape in which a series of cutouts are created within the donut ring, as shown in FIG. The plurality of cutouts 610 removes the material from the reflector layer, connecting the shapes of the reflector layers and creating a band of material that is generally retained. Each cutout 610 may have an outer edge 602, an inner edge 606, and a strut 604 on each side. In some embodiments, one or more of the outer edges 602, inner edges 606, and struts 604 serve as stress concentration areas or volumes (generally referred to herein as stress concentration points). Can be fulfilled. The stress concentration point can amplify the stress when pressure is applied to the base layer, and subsequently the pressure can be dispersed throughout the PECL device.

In some embodiments, the reflector layer may have a mesh structure, as shown in FIG. Individual columns throughout the mesh structure serve as stress concentration points and can amplify stress when pressure is applied to the base layer (not shown). In some embodiments, the individual cutouts or individual openings 702 may concentrate the stress in the opening area through the edge struts 706 or radial struts 704. The stanchions can have any orientation and the openings can be of any size and shape.

In some embodiments, IOP measurements can result from one stress concentration area. In some embodiments, the IOP calculation can be performed using several stress concentration areas. In some embodiments, all stress concentration areas can be used to determine the IOP value.

An example of measuring stress using a PECL device is shown here in FIG. Here, two images were presented side by side and the photoelastic response of the device was measured in transmission mode using circularly polarized illumination from the bottom and an analyzer in front of the camera. The left figure shows the IOP value of about 15 mmHg, and the image on the right shows the IOP pressure of about 60 mmHg. The change in light intensity measured between the two images can be observed as a function of the stress evoked within PECL. The change in light intensity may be more pronounced in the stanchions 804 between the cutout 802 openings. A certain amount of stress may also be readable at the outer edge 806.

In another embodiment, a time series plot 900 of the intensity of transmitted light extracted from the measurement of FIG. 8 is shown here in FIG. In certain embodiments, pressure can be applied to the eye model and the intensity can vary linearly. Small step widths up to 1 mmHg can be resolved from a single region of interest (ROI) with a signal-to-noise ratio of about 5 in 30 ms acquisition time. The graph shows the intensity of the reflected light as a percentage of the full scale when the pressure applied to the eye model changes as follows: from 15 mmHg to 60 mmHg and back to 15 mmHg (100-700 seconds) at each step. ); 5 mmHg steps from 15 mmHg to 30 mmHg, and a single step back to 15 mmHg (1,200 to 2,100 seconds); 1 mmHg steps from 15 mmHg to 25 mmHg (starting from 2,200 seconds). By measuring the percent reflection, the graph can be used to infer the IOP level using the multiplication factor, as the sensor can be linear. The detectable pressure difference can be about 0.2 mmHg in real time using a 30 frame / sec (FPS) image rate.

The graph shown in FIG. 9 illustrates laboratory measurements over the course of overall seconds (in X-axis units). In operation, a rotating light analysis measuring device can take a picture and analyze them within a few milliseconds, utilizing a still image capture of a rotating device or camera on a video camera or mobile device.

In some embodiments, the optical rotor 1000 can be used to measure the reflectance of PECL devices, as shown in FIG. An illuminator with a transducer can project the illumination onto the sample device and the reflected light can be imaged through an analyzer with a camera. In some embodiments, the polarimeter can be an optical head 1004 with a light source 1002. The light source 1002 emits light toward the stator 1006. In some embodiments, the splitter may have a linear deflector 1012 and a quarter wave plate 1014 in the path of the light source 1002 to the pupil 1010. Then a set of reflective modulators for the light reflected from the PECL1008 device. These modulators can again be the quarter wave plate 1016 and the linear modulator 1018. In some embodiments, the reflective linear deflector 1018 may have a polarization axis offset by 90 degrees from the transmitted linear splitter 1012. Light passing through the reflector transducers 1016 and 1018 can then be detected and imaged using the camera 1020.

In some embodiments, there may be an optical rotation analysis measuring device, which may be an attachment device for connecting to a mobile device such as a mobile phone. In some embodiments, the attachment device may have a built-in light source such as an LED light engine. In some embodiments, the attachment device may have a camera. In some embodiments, the attachment device utilizes a camera built into the mobile device, and the attachment device is a software program for controlling the mobile device and the attachment device for determining a measured value from PECL1008. App) can be used. In some embodiments, PECL can be PEIL.

In some embodiments, the illuminator with a modulator can project the illuminator onto a sample PECL1106 device, the reflected light can be imaged through an analyzer 1104 controlled by the microcontroller 1102, and the image is It may be photographed using a timed camera 1108.

In some embodiments, an illuminator with narrowband computer controlled light, along with a splitter, may project the illuminator onto the sample PECL device. The reflected light can be imaged through a computer controlled analyzer. The reflected light can pass through a narrowband optical filter and be imaged using a timed camera 1108. In some embodiments, the light can be filtered using a mechanical optical filter to produce a particular polarization of the light source.

In some embodiments, PECL1202 can be read using the optical rotation analysis measuring device 1204, as shown in FIG. Optical rotation analysis and measurement device 1204 may have a body as shown, which is a combination of a light source, various polarization filters, and one or more narrow bandpass filters. Optical rotation analysis and measurement device 1204 may include camera 1206 or may rely on a camera within a mobile device (not shown). The camera and one or more various analyzers in the rotating light analysis measuring device 1204 may utilize a common computer processor 1208 such as a microcontroller in the rotating light analysis measuring device 1204 or a mobile device.

In some embodiments, the polarization meter measuring device may produce appropriately polarized light every few milliseconds. The mobile device app controls the polarization meter measuring device and the camera of the mobile device, properly synchronizes the light generation and image capture, and records the reflected light.

In some embodiments, the optical rotor 1304 can be a consumer electronic device. The consumer electronic device can be a mobile phone attachment, a stand-alone device, or a program (app) for use in a mobile phone or other consumer electronics, as shown in FIG. In some embodiments, an optical rotation analysis measuring device (PMD) may be present. The optical rotation analysis measurement device may have a main body and a circuit contained in the main body. The circuit may have a microcontroller, an analyzer, and an interface connector. The optical rotation analysis measurement device may have a light source that telecommunicationss with the circuit. The light source may have a variable output, which may be regulated through a circuit or a software program that controls the circuit or light source. The PMD may have a stator with a retardation plate. The retardation plate can regulate the output of the light source to produce a particular polarization. In some embodiments, the PMD may also have a camera.

In some embodiments, the optical rotation device 1304 can be an attachment to a mobile device 1306 such as a mobile phone. Optical rotation device 1304 may use a high resolution front side camera 1308 for image capture. The optical rotation device 1304 may have a wavelength control illuminator 1310. Polarization filters and wavelength control illuminators can be embedded within the attachment. The attachment may be controlled by software on the mobile device 1306. Optical rotation device 1304 may project light onto PECL device 1302 and read the reflected light to determine any IOP change in the eye. The user may look directly into the front camera 1308 and the wavelength control illuminator 1310 along the line of sight 1312. The optical rotation device 1304 may use one or more scannable elements on the PECL device 1302 to determine if the line of sight 1312 is correct. Once the line of sight 1312 is determined to be correct, the PECL device 1302 may automatically initiate scanning the PECL device 1302 to obtain a reading for the IOP of the eye. In some embodiments, the scan can be manually triggered or can be triggered by some other means.

In some embodiments, the mobile device may have access to the cloud, either through local WIFI or other short-range wireless systems, or through the use of cellular RF networks. When the mobile device 1306 with the optical rotation device 1304 is connected to the cloud, the PECL device 1302 can be read remotely by a physician or other medical procedure provider.

In some embodiments, the PECL device 1302 (which may be a PEIOL device as an alternative) can be used with the mobile device 1306 and the optical rotation device 1304 (PMD) to form a system for determining eye IOP. The system may have a deformable sensor suitable for installation on or in the eye. The sensor may have one or more stress characteristics associated with the photoelastic material. The sensor can be within the biocompatible body. The system may also have an optical rotation analysis and measurement device (PMD) with a light source and one or more polarization filters. The PMD may be capable of producing polarized light. The system may use a mobile computer device such as a mobile phone, table, or laptop computer. The mobile device may run a software program to capture the image via the camera, which may be part of the mobile device or part of the PMD. The image can be generated from the reflection of polarized light from the sensor. The reflected light may pass through an additional polarizing filter before being captured by the image sensor. In some embodiments, the PMD may have a physical or electronic polarization filter. In some embodiments, the PMD may have a filter that can be inserted between the mobile device camera and the sensor, so that the reflected light is one or more filters of the PMD before the image is captured. Can pass through.

In some embodiments, the PECL or PEIOL device can be part of system 1400. The system 1400 may include a PECL1402 (or PEIOL) device, along with a mobile device 1422 and a portable illuminator, in which the system 1400 includes a microcontroller 1406, an LED optical engine 1408, an LCD splitter driver 1410, a splitter 1412, an analyzer 1418. , And shown to have a camera 1420. In some embodiments, remote signals may be received via wireless connection 1404. The connection may prompt the user to activate the optics or to use the optics to measure a person's IOP. Prompts can be made through optical rotations or through mobile devices 1422. The user may attach the optical rotation to the mobile device, or the mobile device may have an optical rotation built therein. The user may activate an app or other program that may control the optical rotation. The user may align his eyes and PECL1402 with the camera 1420. The microcontroller 1406 can then activate the LED light engine 1408 and the LCD splitter driver 1410 to emit light through the splitter 1412 to the PECL1402 device. In some embodiments, the LED light engine 1408 may have sufficient capacity, whereby the LCD splitter driver 1410 or splitter 1412 may not be required. The light, in the form of a reflected 1416 image, can be reflected from the PECL 1402 and passed through the analyzer 1418 before being captured in the camera 1420. The camera 1420 creates an image, which can then be analyzed by the mobile device 1422 according to an algorithm or program to convert the image into IOP data.

In some embodiments, there may be a process to determine the IOP change measured from the PECL device, as shown in FIG. The process can be designed to compensate for or reduce background optical effects such as reflections and ambient lighting. The process may still allow accurate determination of IOP readings. In some embodiments, optical images from PECL devices on the cornea can be obtained continuously. Lighting can be turned on and off while the polarization is being electronically rotated during the analysis. The captured image can then be used in an image processing algorithm to remove background and geometric drift, while intensity changes can be extracted using the built-in reference location on the PECL device. The data can then be used to infer the IOP value, which can then be reported to the user or to the cloud through the mobile device.

In some embodiments, the process may start from start block 1502 when the user can activate the program or app by loading the app into its mobile device. The process can start with step 1504 rotating an analyzer that can be liquid crystal, mechanical, or electric. Light 1506 can be activated. The light can be part of a mobile device or can be a light built into an optical rotation used as an attachment to a mobile device. The process can then perform one or more image capture 1508 steps and record the image using a camera built into the optical rotation or mobile device. The light is turned off (light off 1510) and one or more additional images can be used to capture the background image using the camera 1512. The program can evaluate the total cycle 1214 and determine if sufficient data has been collected to perform the IOP calculation. If sufficient data is not collected, the process returns to the 1504 step of rotating the analyzer. If sufficient data is captured, the process proceeds to perform image alignment 1516. In image alignment 1516, the device may shift the captured image to minimize geometric drift. Background subtraction 1518 can be performed on each image and each image pair (an image captured in the light-on state and a background image captured in the light-off state). Feature extraction may be performed to identify the stress concentration within the stress concentration area, 1520. The process can then automatically determine the polarization angle and wavelength dependent intensity within the selected region of interest (ROI) 1522. The process can then analyze the results and convert the data into IOP information 1224. The IOP data can then be reported (1526 reporting the IOP), which can appear on the mobile device or be transmitted to the cloud. In some embodiments, the mobile device is physically connected to the computer and the data can be transferred over the cable.

In some embodiments, the image can be captured every few milliseconds. In some embodiments, the images can be captured with a delay of about 100 milliseconds between each image. In some embodiments, the camera may capture a video image of the reflected light and the analysis is performed on the appropriate video frame corresponding to the desired image timing at a particular time. The app can analyze the video into separate frames for analysis.

In some embodiments, there may be a photoelastic intraocular lens (PEIOL) in the form of a device as shown in FIG. In some embodiments, there may be a sensor device for measuring intraocular pressure (IOP) in the form of an implantable lens. The implantable lens may have a body made of a biocompatible elastomer material. The body may be configured to fit in the eye. The body may have a first support leg, which may extend radially from the body. The sensor may have a photoelastic layer with a central opening and a plurality of secondary openings. The secondary opening defines a set of struts, which can act as a stress concentration feature. The photoelastic layer can be embedded within the body. The sensor may have a reflector layer with an occupied area that substantially matches the occupied area of the photoelastic layer. The reflector layer may be adjacent to the photoelastic layer. The gas-filled cavity can be adjacent to either the photoelastic layer or the reflector layer. During operation, changes in intraocular pressure can deform the body. Deformation of the body can stress the photoelastic layer and produce optical results.

In certain embodiments, the PEIOL 1602 device is shown implanted in the eye 1608 on the right side of FIG. PEIOL can be implanted under the natural lens 1606 in the eye. On the left side of FIG. 16, a plan view of the PEIOL device can be seen. The PEIOL may have one or more embedded legs 1610, which may help fix the PEIOL 1602 in place and prevent the PEIOL 1602 from moving out of the eye 1608. The PEIOL may have structural elements similar to the PECL device, the reflector layer 1604 having a plurality of cutout 1612 openings and a strut 1614 associated with each opening. The struts can likewise act to concentrate stress on the PEIOL 1602 devices when the internal pressure of the eye is applied to them.

In some embodiments, the PEIOL device can be 2 μm to 1,000 μm thick. In some embodiments, PEIOL can be between 75 μm and 700 μm. In some embodiments, PEIOL can be 125 μm to 300 μm.

In some embodiments, the IOP sensing device can take the form of an intraocular lens (PEIOL) device, as shown in FIG. The PEIOL device 1700 may have an elastomer body 1702 with one or more embedded leg 1704 extensions. The embedded leg 1704 can help stabilize or anchor the PEIOL inside the patient's eye. The photoelastic sensor region may have a photoelastic layer 1706 with a cavity 1708 and a reflector 1710. The assembly of the photoelastic layer 1706, the cavity 1708, and the reflector 1710 can be embedded within the elastomer body 1702. Any IOP change in the eye can directly modulate the pressure on the cavity, and the stress on the upper surface can be modulated due to the mechanical deformation of the cavity, resulting in a photoelastic response.

In some embodiments, the PEIOL device may have different optical properties than the PECL device. Optical sensors used with PEIOL devices may have an automated method of determining whether they are reading PECL or PEIOL devices. Alternatively, there may be a manual indicator for the user to select or toggle between PEIOL or PECL devices.

In some embodiments, the PEIOL may have a cavity 1810 located below the reflector 1808 and within the photoelastic layer 1806. The photoelastic layer 1806 may be included in the body 1804. One or more embedded legs 1802 may extend from the body 1804 to anchor the PEIOL device in place in the eye.

The subjects and embodiments of operation described herein are digital electronic circuits, or computer software, firmware, or hardware, or any of them, comprising the structures and structural equivalents thereof disclosed herein. It can be implemented in a combination of one or more. An embodiment of the subject described herein is one or more computer storage for execution by one or more computer programs, i.e., a data processing apparatus such as a processing circuit, or to control its operation. It can be implemented as one or more modules of computer program instructions encoded on the medium. Processing circuits such as controllers or CPUs are any digital and / or analog circuit configurations configured to perform the functions described herein, such as microprocessors, microcontrollers, application-specific integrated circuits, programmable logic, and the like. May have elements. Alternatively, or in addition, a program instruction is an artificially generated propagating signal, which is generated to encode information for transmission to a suitable receiver device for execution by a data processing device. For example, it can be encoded on machine-generated electrical, optical, or electromagnetic signals.

A computer storage medium is, or is contained within, a computer-readable storage device, a computer-readable storage board, a random or serial access memory array or device, or a combination of one or more of them. obtain. Further, although the computer storage medium is not a propagating signal, the computer storage medium can be the source or destination of computer program instructions encoded within the artificially generated propagating signal. The computer storage medium may be, or may be contained within, one or more separate components or media (eg, multiple CDs, discs, or other storage devices). Therefore, computer storage media are both tangible and non-transient.

The operations described herein are implemented as operations performed by a data processor on data stored on one or more computer-readable storage devices, or data received from other sources. obtain. The term "data processing device" or "computing device" is an example of any kind of device or device for processing data, including programmable processors, computers, systems on a chip, or multiples or combinations of those mentioned above. , And machines. The device may include a special purpose logic network, such as an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). The device, in addition to the hardware, is code that creates an execution environment for the computer program, such as processor firmware, protocol stack, database management system, operating system, cross-platform runtime environment, virtual machine, or one of them. It may also include code that constitutes a combination of one or more. The device and execution environment can implement a variety of different computing model infrastructures such as web services, distributed computing, and grid computing infrastructure.

A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpretive languages, declarative or procedural languages, and is a stand-alone program. It can be deployed in any form, including as, or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. Computer programs are not required, but can accommodate files in the file system. A program may be part of a file that holds other programs or data (eg, one or more scripts stored in a markup language document), in a single file dedicated to that program, or in multiple collaborations. It may be stored in a file (eg, a file that stores one or more modules, subprograms, or parts of code). Computer programs can be run on one computer or multiple computers located in one facility, or distributed across multiple facilities and deployed to be interconnected by communication networks.

The processes and logical flows described herein are by performing actions by having one or more programmable processors execute one or more computer programs, acting on input data and producing outputs. Can be carried out. Processes and logic flows can also be implemented by special purpose logic networks, such as FPGAs (Field Programmable Gate Arrays) or ASICs (Application Specific Integrated Circuits), and devices can be implemented as such.

Suitable processors for running computer programs include, for example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. In general, the processor will receive instructions and data from read-only memory and / or random access memory. An integral part of a computer is a processor for performing actions according to instructions and one or more memory devices for storing instructions and data. In general, computers also include, or receive data from, or transfer data to one or more large storage devices for storing data, such as magnetic, magneto-optical disks, or optical discs. Or will be operably combined to do both. However, the computer does not need to have such a device. In addition, the computer may be another device, such as a mobile phone, personal digital assistant (PDA), mobile audio or video player, game console, Global Positioning System (GPS) receiver, or portable storage device, to name a few. For example, it can be embedded in a universal serial bus (USB) flash drive). Suitable devices for storing computer program instructions and data are, for example, semiconductor memory devices such as EPROM, EEPROM, and flash memory devices, magnetic disks such as internal hard disks or removable disks, optomagnetic disks, and Includes all forms of non-volatile memory, media, and memory devices, including CD ROMs and DVD-ROM discs. Processors and memory may be complemented or incorporated into a special purpose logic network.

In order to provide interaction with the user, embodiments of the subject described herein are display devices such as CRT (Brown Tube Display) or LCD (Liquid Display) monitors, OLED (Organic Light Emitting Diode) monitors, and the like. Alternatively, it may be implemented on a computer having another form of display for displaying information to the user and a keyboard and / or pointing device, eg, a mouse or trackball, which allows the user to provide input to the computer. Other types of devices can likewise be used to provide user interaction. For example, the feedback provided to the user can be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback, and input from the user can be any form of sensory feedback, including acoustic, spoken, or tactile input. Can be received in form. In addition, the computer sends the document to the device used by the user and then receives the document, for example, in response to a request received from a web browser, to send a web page to the web on the user's client device. It can interact with the user by sending it to the browser.

The present specification includes many specific embodiment details, which are construed as an explanation of features specific to a particular embodiment, rather than as a limitation with respect to any embodiment or the scope of what can be claimed. It should be. Certain features described herein in the context of separate embodiments can also be implemented in combination within a single embodiment. Conversely, the various features described in the context of a single embodiment can also be implemented separately or in any suitable secondary combination within multiple embodiments. Further, the features are described above to act in a combination and may be so claimed first, but one or more features from the claimed combination are in some cases excluded from the combination. The solicited combination can be a sub-combination or a variant of the sub-combination.

Similarly, the movements are depicted in the drawings in a particular order, which is because such movements are performed in the particular order shown, or in a sequential order, or all illustrated movements. Should not be construed as requiring that be carried out to achieve the desired result. In some situations, multitasking and parallel processing can be advantageous. Moreover, the separation of the various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and the program components and systems described will include. It should be understood that, in general, it can be integrated within a single software product or packaged within multiple software products.

Reference to "or" is included such that any term described using "or" may indicate any one, two or more of the terms described. Can be interpreted as a term.

Accordingly, specific embodiments of the subject are described. Other embodiments are also within the scope of the following claims. In some cases, the actions listed in the claims are performed in a different order and can still achieve the desired result. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order or sequential order shown to achieve the desired result. In certain embodiments, multitasking and parallel processing can be advantageous. In some embodiments, one or more graphics processing units (GPUs) may be used.

Although certain embodiments of the method and system have been described, it will be apparent to those skilled in the art that other embodiments incorporating the concept may be used herein. The system described above may provide any or more of their components, which may be distributed on any of the stand-alone machines or, in some embodiments, decentralized. It should be understood that it can be provided on multiple machines in the system. The systems and methods described above may be implemented as methods, devices, or manufactured products that use programming and / or engineering techniques to generate software, firmware, hardware, or any combination thereof. In addition, the systems and methods described above may be provided as one or more computer-readable programs embodied on or within one or more manufactured products. As used herein, the term "manufactured" refers to one or more computer-readable devices, firmware, programmable logic, memory devices (eg, EEPROM, ROM, PROM, RAM, SRAM, etc.), hardware. (For example, integrated circuit chips, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), etc.), electronic devices, computer-readable non-volatile storage units (eg, CD-ROMs, floppy® disks). , Hard disk drive, etc.) and is intended to contain the code or logic embedded therein. The product may be accessible from a file server that provides access to a computer-readable program via network transmission lines, wireless transmission media, signal propagation through space, radio waves, infrared signals, and the like. The product can be a flash memory card or magnetic tape. The product contains hardware logic and software or programmable code that is executed by the processor and embedded in a computer-readable medium. In general, computer readable programs can be implemented in any programming language such as LISP, Perl, C, C ++, C #, PROLOG, or any bytecode language such as JAVA®. The software program may be stored as object code on or within one or more manufactured products.

Although the description described above allows one of ordinary skill in the art to make and use what is currently considered to be the best embodiment thereof, one of ordinary skill in the art will be able to modify the specific embodiments, methods, and examples herein. You will understand and recognize the existence of examples, combinations, and equivalents. The present disclosure should therefore be limited not by the embodiments, methods and examples described above, but by all embodiments and methods within the scope and spirit of the present disclosure.

Claims (20)

A device for conforming to the surface contour of the eye, said device.
A body made of a biocompatible material, wherein the body is shaped to resemble a contact lens.
It is equipped with a stress sensor embedded in the main body.
The stress sensor is
An annular ring having a central opening and a plurality of secondary openings arranged around the central opening, wherein the plurality of secondary openings define a plurality of struts, and the annular ring is made of a photoelastic material. An annular ring and an annular ring, wherein the shape of the annular ring, the opening, and the plurality of secondary openings is made to define an occupied area of the annular ring.
A layered reflector material underneath the annular ring
The reflector material has substantially the same occupied area as the annular ring and
The strut of the annular ring is a device capable of bending in response to changes in the surface contour of the eye. The device according to claim 1, wherein the main body has a thickness of about 2 μm to 1,000 μm. The device of claim 1, wherein the reflector material further comprises a plurality of pores. The device of claim 1, wherein the occupied area is irregular. The device of claim 1, wherein the photoelastic layer is a UV curable epoxy. The device according to claim 1, wherein the support column is a stress concentration feature. The device according to claim 1, wherein the photoelastic material rotates a light polarizing surface. The device of claim 1, wherein the stress sensor further comprises a cavity adjacent to the reflector layer or the annular ring. An intraocular lens for measuring intraocular pressure (IOP) in the eye, the intraocular lens is
A body made of a biocompatible elastomer material, wherein the body is configured to fit in the eye.
A first support leg portion, wherein the first support leg portion includes a support leg portion extending radially from the main body and a support leg portion.
A photoelastic layer having a central opening and a plurality of secondary openings arranged in a ring around the central opening, the secondary opening defining a plurality of struts, the struts being a plurality of stresses. Acting as a centralized feature, the photoelastic layer is a photoelastic layer embedded within the body.
A reflector layer having an occupied region substantially matching the photoelastic layer, wherein the reflector layer is a reflector layer adjacent to the photoelastic layer.
It comprises a first gas-filled cavity adjacent to one of the photoelastic layer and the reflector layer.
An intraocular lens in which changes in the IOP in the body cause deformation of the photoelastic layer and produce optical results. The intraocular lens according to claim 9, wherein the main body has a thickness of about 2 μm to 1,000 μm. The intraocular lens according to claim 9, wherein the photoelastic layer is made of a UV curable epoxy. An optical rotation analysis / measurement device for reading optical data and generating IOP data, wherein the optical rotation analysis / measurement device is used.
With the main body
A circuit contained within the body, wherein the circuit comprises a microcontroller, an analyzer, and an interface connector.
A light source that electronically communicates with the circuit, wherein the light source has a variable output, and the variable output is controlled through the circuit.
A splitter with a retarder, wherein the retarder can adjust the output of the light source to generate a particular polarization.
Equipped with a camera capable of continuously capturing images from PECL or PEIL devices,
The device is an optical rotation analysis measurement device capable of evaluating an image captured by the camera and calculating an IOP reading for the eye. 12. The device of claim 12, wherein the interface connector is adapted to connect to a consumer mobile device. The process of determining the intraocular pressure of the eye, said process
Using a camera to collect multiple images of a PECL or PEIL device under first and second illumination conditions,
Using a computer to align the plurality of images, the alignment of the plurality of images eliminates geometric drift from the plurality of images.
Using a computer to filter the multiple images,
Using a computer to locate multiple stress concentration areas in the multiple images,
A process that includes analyzing the stress concentration area and determining the IOP value using a computer. The process of claim 14, wherein the geometric drift is generated by the camera position. The process of claim 14, wherein the filtering process comprises an image data reduction process. 14. The process of claim 14, wherein the process further comprises relating a stress reading to a pressure value with reference to a look-up table using a memory device. It is a system for measuring the intraocular pressure of the eye, and the system is
A deformable sensor suitable for installation on the eye, wherein the stress sensor is a deformable sensor having a biocompatible body and a photoelastic sensor.
An optical rotation analysis / measurement device, wherein the optical rotation analysis / measurement device has a light source and a plurality of polarization filters and can generate polarized light.
Equipped with a mobile computer device with a camera,
The mobile computer device uses the camera to run a computer program to capture at least one image, the image being generated from the polarized light reflected from the sensor and being reflected and polarized. The emitted light passes through at least one polarizing filter prior to image capture, a system. The system according to claim 18, wherein the mobile computer device is a mobile phone. 18. The system of claim 18, wherein the mobile computer device further comprises a program for analyzing a plurality of images and determining an IOP value.

Images