Patent ID: 12257079

DETAILED DESCRIPTION

The present disclosure is hereby further described in detail. The embodiments described below are exemplary, which are intended to explain the present disclosure and cannot to be construed as limitations to the present disclosure. Based on the embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in the field without creative work fall within the scope of protection of the present disclosure.

In order to solve the problem that tonometers in the prior art can be only used for single measurement or have low accuracy, the present disclosure provides an IOP sensor, as shown inFIGS.1and4. The IOP sensor includes: a transmission film component102, which is in direct contact with intraocular aqueous humor for sensing the pressure fluctuations of the intraocular aqueous humor and has a transmission film body on which a cladding layer can be arranged to increase transmissivity; a reflective film component104, which is set on the inner side of the transmission film component102and has a reflective film body of either a printed layer mirror with strong reflectivity or a flat mirror with zero curvature corresponding to the shape of the transmission film component102; and an adhesion layer component106, which is set on the inner layer of the reflective film component104configured to connect to an attachment device that can be a medical device that performs a specific function, such as a drainage tube for the treatment of glaucoma. The enclosed space formed by the reflective film component104and the transmission film component102constitutes a resonance chamber110, which is filled with a filling medium to form a certain pressure within the resonance chamber110.

During use, the IOP sensor can be implanted into the anterior chamber of the patient's eye to make the transmission film component102come into contact with the aqueous humor in the eye, so that the intraocular aqueous humor and the filling medium are located on both sides of the transmission film component102. When the pressure of the aqueous humor in the eye is changed, the pressure difference between the filling medium in the resonance chamber110and the aqueous humor in the eye will also be changed due to the constant pressure of the filling medium in the chamber, which causes deformation of the transmission film component102, thus resulting in the change of the thickness of the resonance chamber110, that is, the distance between the transmission film component102and the reflective film component104and the change of reflection spectrum. As shown inFIG.6, when the sensor is irradiated with in vitro NIR light, the deformation of the transmission film component results in the change of the NIR spectrum as reflected by the reflective film component104. The external receiver receives the reflection spectrum to analyze the characteristic wave and IOP value for the purpose of the detection of IOP according to the change of the NIR spectrum. The preferred wavelength range of the NIR light is 800 nm to 2000 nm for the present disclosure.

The transmission film component102constitutes the external profile of the IOP sensor, and the transmission film component102, reflective film component104and adhesion layer component106are all of annular structure. The adhesion layer component106has an internal columnar cavity108. The specific structure and size can be set according to demand.

The IOP sensor provided by the present disclosure is simple in structure and convenient in operation, and has the ability of continuous non-invasive detection of IOP. The sensor is intended to be implanted into the anterior chamber of the patient's eye to directly measure the pressure of anterior aqueous humor by utilizing the principle of multibeam interference according to the change in pressure difference between aqueous humor and a filling medium, which, on the one hand, reflects the real IOP of patients and improves the accuracy of measurement results, and on the other hand, enables patients to conduct self-detection at any time without the operation of doctors and solves the problem that tonometers in the prior art can be only used for single measurement, thus improving the comprehensive performance of the IOP sensor.

Although the existing Triggerfish CLS can also be used for continuous monitoring of IOP, it cannot be implanted and may affect patients' field of view when being worn. Moreover, the IOP sensor is used for measuring IOP according to the change of corneal curvature with the change of the IOP, which cannot be used for direct measurement of IOP, with low accuracy of measurement results.

The IOP sensor provided by the present disclosure can be used not only for continuous measurement but also for direct measurement of IOP, which improves the accuracy of measurement results, thereby improving the comprehensive performance of the IOP sensor.

The IOP sensor provided by the present disclosure can be manufactured by such methods as light curing micro-nano printing, gas phase precipitation, mold forming, and two-photon printing, which is preferred for integrated printing molding for the present disclosure. The transmission film component102, the reflective film component104and the adhesion layer component106are preferably made of light curing material, which can be any light curing material in the prior art suitable for implantation in the patient's eye, such as the material made by curing with light-cured resin, the material made by curing with light-cured resin and monomer, or the material made by curing with various light-cured resins.

In order to improve the sensitivity of detection, the external surface of the preferred transmission film component102is of surface plasmon structure for the present disclosure to increase the amplitude of reflected light.

The surface plasmon structure is a lattice or boss structure which can be nano-gold lattice formed by gold printing.

In order to ensure the detection effect, the diameter range of each dot in the lattice structure preferred for the present disclosure is 300 nm to 800 nm, and the lattice range corresponds to the position of the reflective film component104.

In order to further improve the sensitivity of detection, the reflective film component104preferred for the present disclosure is designed with a total reflection structure to enhance the reflection ability, so as to improve the sensitivity of detection.

The total reflection structure preferred for the present disclosure is in pyramid array.

For the IOP sensor provided by the present disclosure, the refractive index of the reflective film component104can also be increased by choosing a material with high refractive index for it, so as to improve the sensitivity of detection. Specifically, the material with high refractive index for the present disclosure refers to the material whose refractive index is greater than 1.5.

In order to further improve the refractive index, the material doped with inorganic nanoparticles is preferred for the reflective film component104in the present disclosure, and the material doped with inorganic nanoparticles with high refractive index is more preferred. The inorganic nanoparticles can be selected from at least one of Ge, Bi, SiN and SiO2.

The filling medium in the resonance chamber110in the present disclosure can be any liquid or gas that can exist stably in the resonance chamber110for the convenience of measuring the change of aqueous humor pressure in the eye.

When the filling medium is a liquid, the liquid may be selected from either an uncured light-curing material or glycerol; when the filling medium is a gas, the gas can be selected from any one of the air, oxygen and inert gas.

Specifically, the uncured light-curing material can be an uncured light-curing material for printing the overall structure of the IOP sensor, that is, a printed material.

Specifically, as a certain amount of fluid is needed to serve as the filling medium in the resonance chamber110, a certain amount of printing material may be retained in the resonance chamber110in the printing process of the IOP sensor. The printing material is the uncured light curing material, which can directly serve as the filling medium.

If a fluid other than the printing material, such as glycerin, air or inert gas, is selected as the filling medium, it is necessary to set a drainage hole (for example, drainage hole210as shown inFIG.10) on the adhesion layer component106to be connected with the resonance chamber110in the manufacturing process of the IOP sensor for discharging the printing material retained in the resonance chamber110in printing process and for filling required filling medium into the resonance chamber110. The diameter range of the drainage hole preferred for the present disclosure is 10 μm to 50 μm.

Besides, after filling the filling medium into the resonance chamber110, it is also necessary to seal and block the drainage hole to have it disconnected with the resonance chamber110. To be specific, the drainage hole can be blocked by making a cylinder matching the inner cavity of the adhesion layer component106and externally painted with a photosensitive adhesive to be inserted into the inner cavity108of the adhesion layer component106and fitted closely with the inner cavity108of the adhesion layer component106by aid of light. The cylinder inserted into the adhesion layer component106can be extended axially beyond the IOP sensor, while the extended part can be secured on the tissue.

The overall structure of the IOP sensor in the present disclosure can be of prism, cylinder and other geometric structure. One structure for the IOP sensor is as follows: the front segment208is cylindrical, with a diameter of 250 μm to 500 μm, a wall thickness of 50 μm to 100 μm, and a length of 250 μm to 1000 μm; the middle segment204is polyhedral or cylindrical, with the envelope of polyhedral edge206located in the external profile of the front segment208and spaced 2 μm to 20 μm apart; the end segment202is of round table structure with a certain gradient, whose large end is in contact with the middle segment204, with a wall thickness of 50 μm to 100 μm, a height of 250 μm to 1000 μm, and a slope of 5° to 30°; the reflective film component104is polygonal with single feature or of a closed structure formed by feature polygons. Another structure for the IOP sensor is as follows: The IOP sensor has an external square cylinder structure and an internal cylindrical cavity. See the above descriptions for specific sizes.

The IOP sensor provided by the present disclosure is small in size and can be implanted into the eye through minimally invasive surgery with little damage to human body.

For embodiment, of the existing IOP sensors, EYEMATE is an implantable IOP sensor for in situ measurement. The sensor is equipped with a special integrated chip (MEMS-ASIC) and integrated with an antenna, an induction coil, etc., which can directly sense IOP through the pressure sensor and wirelessly transmit the IOP data. The sensor power supply powers the sensor under the principle of magnetic induction. The encapsulated EYEMATE has an inner diameter of 7 mm and outer diameters of 11.3 mm, 11.7 mm and 12.1 mm. ASIC has a thickness of 0.9 mm, or otherwise 0.5 mm around the microcoil. Its surface is in lenticular round shape for smoothly accommodating the curved sclera shape. The second-generation EYEMATE is structurally improved compared with the first-generation EYEMATE, with the size of 7.5×3.3 mm, the peripheral thickness of 0.9 mm, and the central thickness of 2.2 mm. Due to its large size, EYEMATE needs to be surgically implanted, which brings a certain risk of infection and inconvenience for replacement and maintenance if it's damaged.

Compared with the existing EYEMATE IOP sensor, the IOP sensor provided by the present disclosure is reduced in size by 1 to 2 orders of magnitude, which can be implanted into the eye by minimally invasive method to reduce the harm to human body.

In addition, the IOP sensor provided by the present disclosure can also be connected with a drainage device with the function of drainage of aqueous humor through the attachment device to make the IOP sensor highly scalable.

In order to make the above purposes, characteristics and advantages of the present disclosure more obvious and easily understandable, the specific embodiments of the present disclosure are explained in detail in combination with the drawings below.

Embodiment 1

The embodiment provides an IOP sensor suitable for minimally invasive implantation into the anterior chamber of the patient's eye, as shown inFIG.1. The IOP sensor has an overall shape of square column and internal shape of column. As shown inFIGS.2and3, the IOP sensor has an appearance size of 0.2×0.2×0.31 mm, with the height of 0.31 mm composed of 0.005 mm for upper and lower parts of the resonance cavity cover respectively and 0.3 mm for the intermediate part of the effective detection region. In the embodiment, the IOP sensor has an inner round cavity diameter of 0.15 mm, which is also the diameter of the inner cavity of the adhesion layer component106, whose size mainly depends on the size of the attachment device and can be adjusted as appropriate according to it. The IOP sensor has a film thickness of 0.002 mm, which is also the thickness of the transmission film component102. The resonance chamber110has an inner cavity thickness of 0.015 mm, and the reflective film component104has a thickness of 0.008 mm. As thus, the transmission film component102, the resonance chamber110and the reflective film component104have an overall thickness of 0.025 mm. As shown inFIG.3, the cover has a thickness of 0.023 mm.

The IOP sensor in the embodiment is printed integrally by two-photon printing technology, and the filling medium in the resonance chamber110is printing material, with no need for drainage hole.

Embodiment 2

The embodiment provides an IOP sensor suitable for minimally invasive implantation into the anterior chamber of the patient's eye, as shown inFIG.4. The TOP sensor has an overall appearance of cylinder, with an internal structure of round cylinder.

As shown inFIG.5, the IOP sensor has an overall height of 1.25 mm, an outer diameter of 0.3 mm and an inner diameter of 0.22 mm. The transmission film component102has a thickness of 0.002 mm, and the resonance chamber110has a thickness of 0.007 mm. The adhesion layer component106is provided with a drainage hole connected with the resonance chamber110.

Detection Example

In the detection example, the IOP sensor provided in Embodiment 1 is used for detection according to the detection method shown inFIG.6. The detection spectrum shown inFIG.7contains the comprehensive spectrum of the resonance cavity thickness. The amount of characteristic waves is analyzed by fast Fourier transform to obtain the spectrum as shown inFIG.8. The detection spectrum is subject to filtering processing according to analyzed characteristic waves to obtain the characteristic spectrum as shown inFIG.9. The thickness of the resonance chamber110is calculated according to the characteristic spectrum, and the IOP is further calculated according to the thickness.

The specific calculation process of IOP is as follows:

According to the calculation formula of the cavity length (resonance cavity thickness) of Fabry-perot (F-P) Cavity: fsr=λ2/2 nL.

Wherein, fsr is the distance between two troughs; λ is the mean wavelength between two troughs; n is the refractive index of the filling medium; and L is the thickness of the resonance cavity. The characteristic cavity thickness of the resonance cavity is calculated according to the spectral analysis results inFIG.9. Under the pressure of aqueous humor in the glaucoma patient's eye, the transmission film component102is deformed to a certain degree, while the aqueous humor pressure changes proportionally with the decrease of the cavity thickness. On this basis, the patient's intraocular aqueous humor pressure (namely IOP) is obtained.

Inspired by the above ideal embodiments according to the present disclosure, the relevant staff can make various changes and modifications without deviating from the technical idea of the present disclosure based on the above descriptions. The technical scope of the present disclosure is not limited to the contents in the specification, and the technical scope must be determined according to the scope of the claims.