CN112450877A - Intelligent contact lens with full-cornea fiber grating sensors arranged in series - Google Patents
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Abstract
本发明公开了一种全角膜光纤光栅传感器串联排布的智能接触镜，包括软性接触镜和硬性接触镜；所述软性接触镜配戴后位于患者眼球角膜上，其内设置有用于监测眼压的眼压监测传感器；所述眼压监测传感器为光纤光栅传感器，所述光纤光栅传感器包括光纤和分布制作在光纤上的多个光栅；多个光栅在软性接触镜内排布于角膜的近中央及周边区域，且各光栅在眼压测量范围内具有可相互区分的反射波长；所述硬性接触镜设置在软性接触镜的外侧，配戴后将软性接触镜包覆在内并对后者进行限位或固定，阻止软性接触镜相对于角膜移动或转动。本发明通过光栅串联设计，形成传感网络，提高了眼压监测的灵敏性、准确性与可重复性。
The invention discloses an intelligent contact lens in which all corneal fiber grating sensors are arranged in series, including a soft contact lens and a hard contact lens; the soft contact lens is located on the cornea of a patient's eyeball after being worn, and is provided with a monitor for monitoring An intraocular pressure monitoring sensor for intraocular pressure; the intraocular pressure monitoring sensor is a fiber grating sensor, and the fiber grating sensor includes an optical fiber and a plurality of gratings distributed on the optical fiber; the plurality of gratings are arranged on the cornea in the soft contact lens The near-central and peripheral regions of the lens are in the near central and peripheral regions, and each grating has mutually distinguishable reflection wavelengths within the intraocular pressure measurement range; the rigid contact lens is arranged on the outside of the soft contact lens, and the soft contact lens is covered after wearing. The latter is limited or fixed to prevent the soft contact lens from moving or rotating relative to the cornea. The invention forms a sensor network through the series design of gratings, and improves the sensitivity, accuracy and repeatability of intraocular pressure monitoring.
Description
Technical Field
The invention relates to an eye pressure monitoring device, in particular to an intelligent contact lens with all-cornea fiber grating sensors arranged in series.
Background
The intraocular pressure value of a normal person is 10-21 mmHg, and the day and night fluctuation is within 8mmHg, so that the basis for maintaining the visual physiological function is provided. When the ocular tension or/and the diurnal fluctuation range of the ocular tension exceed the normal range, the pathological increase of the ocular tension and the diurnal fluctuation of the pathological ocular tension are called, and the irreversible damage of the visual function is caused. In the early stage of glaucoma, the diurnal fluctuation range of intraocular pressure can reach 2-3 times of that of normal people. Therefore, attention to pathological circadian fluctuations in ocular pressure has become a consensus among glaucoma experts worldwide.
The diurnal fluctuations in pathological ocular pressure are very insidious, and it has been reported that the peak of diurnal fluctuations in ocular pressure occur at night (23: 30-05: 30), whether in a sitting or lying position. At present, the conventional method for monitoring diurnal fluctuation of intraocular pressure worldwide is to use a single intraocular pressure measuring instrument to measure intraocular pressure once every 2 hours within 24 hours and draw up a diurnal fluctuation curve of intraocular pressure. The problems of the method are that: 1) the actual conditions of intraocular pressure under the natural vegetative nerve regulation state, such as sleep, movement, free movement and the like, cannot be obtained; 2) the intraocular pressure value of 12 points cannot completely reflect the full appearance of intraocular pressure fluctuation in 24 hours; 3) the errors between single measurements of 12 points and between measurements of each point all affect the observation results. Therefore, the method cannot meet the requirements of clinical diagnosis and treatment, and cannot meet the requirement of exploring the diurnal fluctuation mechanism of intraocular pressure.
In order to realize the real-time monitoring of intraocular pressure for 24 hours, a large number of researchers are involved in the development of long-range intraocular pressure monitors. Some integrate the MEMS pressure sensor, the micro communication inductance coil, the signal processing circuit, etc. into a whole, and implant the integrated sensor into the eye for operation to obtain the intraocular pressure variation signal. The advantage is direct detection of intraocular pressure, but is invasive to the eye and has risks of infection and unpredictable, and in addition the problems of biocompatibility and longevity of the sensor also limit its application. Based on this, the non-invasive wearing type long-range intraocular pressure monitoring method is the main research direction, and the principle is that according to the biological characteristics of corneal strain caused by intraocular pressure change, a contact lens with a sensor function, also called an intelligent contact lens, is worn to sense the corneal strain amount during intraocular pressure change and convert the corneal strain amount into intraocular pressure change information, thereby achieving the purpose of continuously monitoring intraocular pressure in a long range. Around the world, there have been developed wearing-type long-range intraocular pressure monitoring methods: based on microfluid intelligence contact lens, MEMS capacitive contact lens, based on little capacitive radio frequency integrated circuit intelligence contact lens, based on wireless passive resonant mode intraocular pressure monitoring system of C-L-C structure, because the intraocular pressure sensor that meets resistance strain, nevertheless because face difficult problems such as manufacturing process, in vivo application, all stop at the isolated sensor sensitivity verification stage.
At present, only an intelligent contact lens intraocular pressure monitor (Triggerfish) with a MEMS micro strain gauge enters an in-vivo clinical verification stage, but the problems of unstable sensitivity and repeatability are proved to exist. The reasons for instability of tonometry were analyzed as follows: 1) the problem of corneal strain difference: the cornea is in a transverse ellipse shape (the transverse diameter is 11.5-12mm, and the vertical diameter is 10.5-11 mm); thin (0.55mm) in the center of the cornea and thick (1mm) in the periphery; the corneal collagen fibers are arranged in parallel, the sclera is arranged in a cross way, and the corneoscleral edge is a transitional area of the arrangement of the two fibers, and the anatomical characteristics determine that the strain quantity of each position and area of the cornea is different when the intraocular pressure is changed, namely the corneal strain difference. The thin part of the cornea and the fiber arrangement transition area have large strain. When the intraocular pressure changes, the amount of strain generated at different sites and areas of the cornea is different. When the intraocular pressure is repeatedly detected for many times, if the sensor is inconsistent with the detected cornea site due to wearing of the contact lens, or the contact lens moves the position in the long-range intraocular pressure monitoring process, the corresponding relation between the sensor and the detected site changes, which will affect the sensitivity and repeatability of the measurement result. 2) Blink, eye movement disturbance problem: the blink and the eye movement cause the displacement of the contact lens, so that the detection site of the sensor is continuously changed, and the signal source acquired by the sensor is uncertain. It follows that stable contact of the sensor with the site to be detected is critical to ensure detection sensitivity and reproducibility. In order to realize accurate long-range intraocular pressure monitoring, the problem of interference of the in-vivo ocular surface environment must be solved.
In addition, when only a single sensor is embedded in the existing intelligent contact lens, the sensor is difficult to be ensured to be in a strain area with enough sensitivity, and the measurement sensitivity is influenced; meanwhile, the contact lens can rotate and displace in a dynamic ocular surface environment, so that a detection area of the sensor can be changed, and the stability of intraocular pressure monitoring is difficult to ensure.
Disclosure of Invention
The invention aims to provide an intelligent contact lens with full cornea fiber grating sensors arranged in series, which can realize intraocular pressure real-time monitoring and improve monitoring accuracy.
In order to achieve the purpose, the intelligent contact lens with the full-cornea fiber grating sensors arranged in series comprises a soft contact lens and a hard contact lens; the soft contact lens is positioned on the cornea of the eyeball of the patient after being worn, and an intraocular pressure monitoring sensor for monitoring intraocular pressure is arranged in the soft contact lens; the intraocular pressure monitoring sensor is a fiber bragg grating sensor which comprises an optical fiber and a plurality of gratings distributed on the optical fiber; a plurality of gratings are arranged in the near-central and peripheral areas of the cornea in the soft contact lens, and each grating has mutually distinguishable reflection wavelengths in the intraocular pressure measurement range; the hard contact lens is arranged at the outer side of the soft contact lens, and the soft contact lens is covered in the hard contact lens and limited or fixed after being worn, so that the soft contact lens is prevented from moving or rotating relative to the cornea. It should be noted that the "intelligent contact lens" referred to in the present invention is relative to the conventional contact lens, and only means that it has intraocular pressure monitoring function, and does not include related software and its improvement.
Preferably, the optical fibers are arranged in a spiral around the center of the soft contact lens, so that the gratings thereon are dispersed in different regions of the cornea.
Preferably, the number of the gratings is 8-10.
Preferably, the pitch of a plurality of said gratings increases from the inside to the outside.
Preferably, the gratings are positioned in the range of 4-8 mm of the central diameter of the soft contact lens.
Preferably, the soft contact lens is manufactured by using a mold forming technology and a fiber grating sensor is coupled in the soft contact lens.
Preferably, the hard contact lens comprises an optical zone at the center and four peripheral arc segments at the periphery, and the four peripheral arc segments are, from inside to outside: 1) a secondary arc extending from the optical zone to the edge of the soft contact lens after being worn, and limiting the edge of the soft contact lens; 2) a transition arc that, after wear, falls on the sclera across the portion of the corneal limbus that is not covered by the soft contact lens; 3) a positioning arc, which is positioned on the sclera after wearing to maintain the whole lens centered and not rotating; 4) the arc is flat and tilted, which is convenient for tear exchange.
Preferably, the diameter of the optical zone is 6-7 mm, and the base curve curvature is designed according to the curvature radius of the center of the cornea; the transition arc is provided with micropores facilitating tear exchange.
Preferably, the diameter of the hard contact lens is 14-15 mm, and a high oxygen-permeable fluorosilicone acrylate material Hexafocon A is adopted.
Preferably, the diameter of the soft contact lens is 10mm, and polyhydroxyethyl methacrylate is adopted.
Compared with the prior art, the invention has the beneficial effects that:
1) the fiber grating sensor can realize multipoint distribution of sensitive areas near the center and near the corneal edge through grating series connection design to form a sensing network, each grating independently outputs wavelength data and independently demodulates the wavelength data, and through combined analysis of a plurality of grating measurement data, on one hand, pressure strain information of the whole cornea is obtained, on the other hand, common mode signal drift interference caused by ocular surface temperature change is eliminated, and accordingly sensitivity, accuracy and repeatability of intraocular pressure monitoring are improved.
2) The fiber grating sensor is tiny, transparent, soft and easy to bend, is coupled inside the contact lens and is not in contact with the cornea, so that the fiber grating sensor can be safely and comfortably worn on the ocular surface for a long time, and 24-hour real-time intraocular pressure monitoring is realized.
3) Utilize hard contact lens to restrain the displacement of coupling to have the soft contact lens of sensor in the ocular surface environment of body, increase the stability of sensor position at the ocular surface, improve measuring result's repeatability, the stabilizing action of outer contact lens simultaneously also makes inlayer contact lens and cornea laminating better, and the sensor perception cornea strain signal more easily, consequently also is more sensitive to the change of eye pressure detection.
Drawings
Fig. 1 is a schematic cross-sectional view of a lens axis of an intelligent contact lens with all-corneal fiber grating sensors arranged in series according to an embodiment of the present invention, in which a cornea and a sclera belong to an eyeball structure, and are only used for indicating a wearing position relationship, and should not be considered as a component of the present invention.
Fig. 2 is an enlarged view of a point a in fig. 1.
Fig. 3(a) and 3(b) are a schematic axial cross-sectional view and a schematic front view of the hard contact lens in fig. 1, respectively.
Fig. 4 is a front view of the soft contact lens of fig. 1, wherein the fiber grating is located inside the soft contact lens, and the structure of the fiber grating is shown in a perspective view.
Wherein: hard contact lens 10, optical zone 11, minor arc 12, transition arc 13, positioning arc 14, circumferential arc 15, soft contact lens 20, optical fiber 21, grating 22, cornea 30, sclera 40.
Detailed Description
The invention is described in further detail below with reference to the figures and the specific embodiments.
As shown in fig. 1, the intelligent contact lens with full-cornea fiber grating sensors arranged in series provided by the present invention includes a hard contact lens 10, a soft contact lens 20, and a fiber grating sensor coupled inside the soft contact lens 20. Wherein:
the total diameter of the hard contact lens 10 is about 14-15 mm, diopter is flat light, and the hard contact lens is designed, cut and customized by adopting a high oxygen-permeable fluorosilicone acrylate material Hexafocono A, and the main parameters are as follows: oxygen permeability coefficient of material>90×10-11(cm2/s)[ml O2/(ml×mmHg)]Shore hardness not less than 80, contact angle not more than 50 degrees, refractive index not less than 1.41 and light transmittanceNot less than 85%; when the lens is broken, the bending deformation is more than 70%, and the load force is not less than 200 g; when the bending deformation of the lens is 30%, the load force is not less than 50 g; lens parameter ranges and processing errors meet GB 11417.2-2012 ophthalmic optical contact lens part 2: hard contact lens ".
As shown in fig. 2 and 3, the hard contact lens 10 is composed of an optical zone 11 located at the center and four peripheral arcs located at the periphery. The optical zone 11 has a diameter of 6-7 mm, and the base curve is designed to match the curvature radius of the center of the cornea. The four peripheral arc sections are sequentially as follows from inside to outside: 1) the secondary arc 12 extends outwards from the optical zone 11 to the edge zone of the soft contact lens 20 under the hard contact lens 10, covers the edge zone so as to limit the soft contact lens 20, and the curvature radius can be spherical or non-spherical according to the shape of the cornea 30 in the corresponding zone; 2) the transition arc 13 strides over the part of the cornea 30 which is not covered by the soft contact lens 20 and falls on the sclera 40, the arc section is relatively flat, the middle part is suspended, the suspended part is not directly contacted with the cornea 30 and the sclera 40, and micropores convenient for tear exchange are arranged on the suspended part; 3) a positioning arc 14, located on the sclera 40, maintaining the overall centering, non-rotation of the lens; 4) the peripheral arc 15, located outermost, is flat and raised so that a gap exists between its outer edge and the sclera 40 to facilitate tear exchange.
The total diameter of the soft contact lens 20 is 10mm, and the soft contact lens is flat and smooth, and is made of a polyhydroxyethyl methacrylate material, and the main parameters are as follows: water content 38%, oxygen permeability coefficient: DK 8.0 ~ 8.5, base arc radius of curvature matches the design according to the radius of curvature at cornea central authorities, and central thickness: 80-100 μm, light transmittance: 92% -98%, the lens parameter range and the processing error meet the requirements of GB11417.3-2012 part 3 of ophthalmic optical contact lenses: soft contact lenses ].
As shown in fig. 4, the interior of the soft contact lens 20 is coupled with a fiber grating sensor by using a molding technique. The fiber grating sensor comprises an optical fiber 21 and 9 gratings 22 arranged on the optical fiber 21 in series, and is also provided with optical signal processing and analyzing software and hardware (provided by a sensor supplier). The diameter of the optical fiber 21 is 10 micrometers, the measuring parts of the optical fiber are spirally arranged around the diameter range of 4-8 mm of the center of the contact lens, the coverage range comprises a near-cornea central strain sensitive area and a near-angle scleral edge cornea strain sensitive area, and therefore enough strain information can be obtained without affecting the vision of a wearer; the grating 22 is a Bragg grating and is prepared on the optical fiber 21 in a femtosecond laser point-by-point direct writing mode; the length of a single grating 22 is 1mm, 9 gratings 22 are arranged in series, the grating distance (the distance between two connected gratings) is increased from inside to outside, and the arrangement mode is favorable for reducing the measurement error and optimizing the measurement result; each grating has a differential period (distance between adjacent indentations within the same grating) such that it has mutually distinguishable reflection characteristic wavelengths over the tonometric measurement range.
The main technical performance and indexes of the device are as follows:
1) intraocular pressure measurement range: 5-60 mmHg;
2) resolution ratio: 0.1 mmHg;
3) stability: the fluctuation range is less than 0.5 mmHg;
4) the accuracy is as follows: 1 mmHg;
5) tolerance: the disposable wearing time is 24 hours, and the activity is free;
6) sampling time interval: collecting 30 seconds of signal change every 5 minutes;
7) safety: compliance with contact lens ISO 14534: 2011E standard for safety wear.
The working principle of the device is as follows:
according to the strain transmission principle, the sensor can sense and transmit strain information of the cornea 30 by closely and stably attaching to the cornea 30. The soft contact lens 20 is the best choice for loading the sensor because of close fit with the cornea 30, but the sensor on the contact lens and the cornea detection site are unstable due to the fact that the sensor is rotationally displaced by blinking and eye movement, and sensitivity and repeatability of the sensor are affected. The hard contact lens 10 can be stably fixed on the surface of the cornea 30 due to the material and design characteristics, and is widely applied to clinical corneal sculpting.
When the intraocular pressure changes, the cornea 30 deforms, the soft contact lens 20 also deforms due to close fit with the cornea 30, each grating 22 respectively senses the corneal strain in the area where the grating is located, corresponding reflection characteristic wavelength changes are generated, the strain quantity of the whole cornea 30 is obtained after analysis and processing, and then the change value of the intraocular pressure is calculated through the linear relation between the intraocular pressure and the corneal deformation. In the process of monitoring the intraocular pressure day and night, the fiber bragg grating sensor periodically acquires the characteristic wavelength and the change of the characteristic wavelength and converts the characteristic wavelength into an intraocular pressure change result, so that day and night continuous monitoring of the intraocular pressure is realized.
The outer hard contact lens 10 improves the stability of the inner contact lens on the ocular surface, can inhibit the interference of winking and eye movement on the position of the sensor, keeps the accurate matching of the sensor and the detected site and improves the stability of measurement.
Claims (10)
1. The utility model provides an intelligent contact lens that full cornea fiber grating sensor was arranged in series which characterized in that: comprises a soft contact lens (20) and a hard contact lens (10);
the soft contact lens (20) is positioned on the cornea (30) of the eyeball of the patient after being worn, and an intraocular pressure monitoring sensor for monitoring intraocular pressure is arranged in the soft contact lens; the intraocular pressure monitoring sensor is a fiber bragg grating sensor, and the fiber bragg grating sensor comprises an optical fiber (21) and a plurality of gratings (22) distributed on the optical fiber (21); a plurality of gratings (22) arranged in the soft contact lens (20) in the near central and peripheral regions of the cornea (30), and each grating having a reflection wavelength distinguishable from each other in the intraocular pressure measurement range;
the hard contact lens (10) is arranged on the outer side of the soft contact lens (20), and the soft contact lens (20) is covered in the hard contact lens after being worn and limited or fixed to prevent the soft contact lens (20) from moving or rotating relative to the cornea (30).
2. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 1, is characterized in that: the optical fibers (21) are arranged in a spiral shape around the center of the soft contact lens (20) in a manner that the gratings (22) on the optical fibers are dispersed in different areas of the cornea (30).
3. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 1, is characterized in that: the number of the gratings (22) is 8-10.
4. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 1, is characterized in that: the pitches of the gratings (22) are increased from inside to outside.
5. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 1, is characterized in that: the gratings (22) are positioned in the range of 4-8 mm of the central diameter of the soft contact lens (20).
6. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 1, is characterized in that: the flexible contact lens (20) is manufactured using a cast molding technique and has a fiber grating sensor coupled thereto.
7. The intelligent contact lens with the full-cornea fiber grating sensors arranged in series according to any one of claims 1 to 6, is characterized in that: the hard contact lens (10) comprises an optical area (11) positioned in the center and four peripheral arc sections positioned on the periphery, wherein the four peripheral arc sections are sequentially from inside to outside: 1) the secondary arc (12) extends outwards from the optical area (11) to the edge of the soft contact lens (20) after being worn, and limits the edge of the soft contact lens (20); 2) a transition arc (13) that, when worn, falls on the sclera (40) across the edge portion of the cornea (30) that is not covered by the soft contact lens (20); 3) a positioning arc (14) for positioning on the sclera (40) after wearing to maintain the overall centering of the lens without rotation; 4) the circumference arc (15) is flat and tilted, so that the tear exchange is facilitated.
8. The intelligent contact lens with the full cornea fiber grating sensor arranged in series according to claim 7, is characterized in that: the diameter of the optical area (11) is 6-7 mm, and the base arc curvature is designed according to the curvature radius of the center of the cornea in a matching way; the transition arc (13) is provided with micropores facilitating tear exchange.
9. The intelligent contact lens with the full-cornea fiber grating sensors arranged in series according to any one of claims 1 to 6, is characterized in that: the diameter of the hard contact lens (10) is 14-15 mm, and a high oxygen-permeable fluorosilicone acrylate material Hexafocon A is adopted.
10. The intelligent contact lens with the full-cornea fiber grating sensors arranged in series according to any one of claims 1 to 6, is characterized in that: the diameter of the soft contact lens (20) is 10mm, and polyhydroxyethyl methacrylate is adopted.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011166010.4A CN112450877A (en) | 2020-10-27 | 2020-10-27 | Intelligent contact lens with full-cornea fiber grating sensors arranged in series |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011166010.4A CN112450877A (en) | 2020-10-27 | 2020-10-27 | Intelligent contact lens with full-cornea fiber grating sensors arranged in series |
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| CN112450877A true CN112450877A (en) | 2021-03-09 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115299874A (en) * | 2022-08-01 | 2022-11-08 | 谢立科 | Night clinostatism intraocular pressure measurement system |
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| DE102007026313A1 (en) * | 2007-06-06 | 2008-12-11 | Zürcher, Ralf | Contact lens comprises a first lens part arranged directly on the eye and made from a soft material and a second lens part arranged on the outer side of the first part and made from a harder material |
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| CN115299874A (en) * | 2022-08-01 | 2022-11-08 | 谢立科 | Night clinostatism intraocular pressure measurement system |
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