Noninvasive tear analysis equipment and evaluation system for comprehensive evaluation of ocular surface health

Abstract

The invention discloses a noninvasive tear analysis device and evaluation system for comprehensive evaluation of ocular surface health, the device has an external form and a corneal contact lens form, and the device comprises a substrate, a capillary drainage structure, a tear component sensing unit, a physical parameter sensing unit and a packaging piece; the capillary drainage structure is arranged on the substrate and is used for collecting and guiding tears from the ocular surface through capillary action; the tear component sensing unit is arranged on the substrate and is in fluid communication with the capillary drainage structure; the physical parameter sensing unit is arranged on the substrate; the packaging piece is connected with the substrate and is used for packaging a structure on the substrate; through the external and corneal contact lens type structural design, noninvasive intervention on the ocular surface is achieved, independent drainage of tears is achieved through the capillary action, external active suction or physical scraping is avoided, and the sampling reliability is guaranteed while the wearing safety and comfort are guaranteed to the maximum extent by combining with a biocompatible material.

Description

Technical Field

[0001] This invention relates to the field of biomedical device technology, and in particular to a non-invasive tear analysis device and assessment system for comprehensive assessment of ocular surface health. Background Technology

[0002] Ocular surface diseases are common and widespread conditions in ophthalmology. Precise diagnosis and treatment of ocular surface diseases rely on a comprehensive assessment of the ocular surface microenvironment. Continuous monitoring of key parameters such as tear electrolytes, pH value, osmotic pressure, and ocular surface temperature is of great significance. It helps in the accurate diagnosis and long-term tracking of various eye diseases, provides a basis for the rational management of therapeutic drug dosages, and lays the foundation for the development of personalized treatment plans. At the same time, it can effectively evaluate the treatment effect.

[0003] Currently, the main clinical methods for tear collection are the Capillary method and the Schirmer strip method. The Capillary method involves placing the tip of a glass capillary tube at the lower edge of the tear duct, collecting tears from the conjunctival sac using capillary action. However, this method requires highly skilled medical personnel, is uncomfortable for patients, and necessitates specialized equipment for subsequent testing, making the process cumbersome. The Schirmer strip method, on the other hand, collects tears using filter paper. The filter paper is placed in the lower eyelid conjunctival sac for 5 minutes. This method is relatively simple and serves as a standard tool for evaluating intraocular tear volume. However, it cannot provide in-depth analysis of tear composition, making it insufficient for comprehensive monitoring of the ocular surface microenvironment.

[0004] While there has been some progress in ocular surface tear film composition monitoring technology both domestically and internationally, several problems still exist. Existing tear film sensors often incorporate color or fluorescence alteration probes into contact lenses to monitor compositional changes, making them susceptible to interference from external factors such as light and ophthalmic medications, thus affecting the accuracy of the results. Furthermore, contact lens systems based on electrochemical sensing often require direct contact between the sensing electrodes and the tear film, which may affect the patient's visual quality and comfort, has poor biocompatibility, and makes it difficult to guarantee comfortable long-term wear.

[0005] In addition, existing electrical signal sensing systems for detecting ocular surface tear components still require doctors to collect tears using capillaries before testing, which is inconvenient and lacks a convenient tear collection system, making it difficult for patients to obtain real-time eye health information comfortably and efficiently. Summary of the Invention

[0006] The purpose of this invention is to provide a non-invasive tear analysis device and assessment system for comprehensive assessment of ocular surface health, so as to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] In a first aspect, the present invention provides a non-invasive tear fluid analysis device for comprehensive assessment of ocular surface health, the device being an external device, comprising:

[0009] Base;

[0010] A capillary drainage structure is disposed on the substrate to collect and guide tears from the ocular surface through capillary action;

[0011] A tear component sensing unit is disposed on the substrate and is in fluid communication with the capillary drainage structure to detect at least one chemical component in the guided tear.

[0012] A physical parameter sensing unit is disposed on the substrate and is used to detect at least one physical parameter of the ocular surface;

[0013] A package, connected to the substrate, for encapsulating a structure on the substrate;

[0014] The capillary drainage structure includes a flexible drainage section disposed on the substrate, one end of which is used to contact and collect tears from the ocular surface.

[0015] In one optional embodiment, the capillary drainage structure is made of a hydrophilic material; at least a portion of the hydrophilic material is bent to form the flexible drainage portion;

[0016] The electrodes of the tear component sensing unit are disposed on the surface of the hydrophilic material.

[0017] In an optional implementation, the capillary drainage structure includes at least one first microchamber assembly;

[0018] The first microchamber assembly includes a first microchannel, a first tear outflow orifice, and a first tear storage pool;

[0019] The inlet end of the first tear fluid storage tank is connected to the flexible drainage part, and the outlet end of the first tear fluid storage tank is connected in sequence to the inlet end of the first microchannel and the first tear fluid outflow hole.

[0020] At least some of the electrodes of the tear component sensing unit are disposed in the first tear storage pool.

[0021] In an optional embodiment, the sensing part of the physical parameter sensing unit is arranged in the bending section of the flexible drainage part so as to be close to the ocular surface during use.

[0022] The leads of the physical parameter sensing unit are arranged adjacent to the electrode leads of the tear component sensing unit.

[0023] In one optional embodiment, the tear component sensing unit is an ion sensing electrode; the ion sensing electrode includes a working electrode, a counter electrode, and a reference electrode, with the working electrode located between the counter electrode and the reference electrode.

[0024] Secondly, the present invention provides a non-invasive tear analysis device for comprehensive assessment of ocular surface health, the device being a corneal contact lens type device, comprising:

[0025] The substrate is a corneal contact lens;

[0026] A capillary drainage structure is disposed within the substrate to collect and guide tears from the ocular surface via capillary action;

[0027] A tear component sensing unit is disposed on the substrate and is in fluid communication with the capillary drainage structure to detect at least one chemical component in the guided tear.

[0028] A physical parameter sensing unit is disposed on the substrate and is used to detect at least one physical parameter of the ocular surface;

[0029] An encapsulation component, connected to the substrate, is used to encapsulate a structure on the substrate.

[0030] In an optional embodiment, the capillary drainage structure includes a second tear discharge orifice and at least one second microchamber assembly;

[0031] The second microchamber assembly includes a second microchannel, a second tear reservoir, and at least one tear collection orifice;

[0032] The tear collection hole is provided through the lens body and is connected to the second tear storage pool, and is used to collect tears from the ocular surface through capillary action.

[0033] The inlet end of the second microchannel is connected to the outlet end of the second tear storage tank, and the outlet end of the second microchannel is connected to the inlet end of the second tear outflow hole.

[0034] At least some of the electrodes of the tear component sensing unit are disposed in the second tear storage pool.

[0035] In an optional implementation, the sensing portion of the physical parameter sensing unit is arranged in a ring around the second microchamber assembly;

[0036] The leads of the physical parameter sensing unit are arranged adjacent to the electrode leads of the tear component sensing unit.

[0037] In an optional embodiment, the sensing electrodes of the tear composition sensing unit are disposed in the non-optical area of ​​the lens;

[0038] The tear component sensing unit is an ion sensing electrode; the ion sensing electrode includes a working electrode, a counter electrode and a reference electrode, and the working electrode is located between the counter electrode and the reference electrode.

[0039] Thirdly, the present invention provides a comprehensive ocular surface health assessment system, characterized in that it includes:

[0040] The non-invasive tear analysis device described in the first aspect above, or

[0041] The non-invasive tear analysis device as described in the second aspect above; and

[0042] The data processing terminal, which is communicatively connected to the non-invasive tear analysis device, is used to receive and process sensor data from the non-invasive tear analysis device to generate ocular surface health assessment results.

[0043] The beneficial effects of the embodiments provided by the present invention include:

[0044] This invention achieves non-invasive intervention on the ocular surface through an external, contact lens-like structural design. It utilizes capillary action to achieve autonomous tear drainage, avoiding external active absorption or physical scraping. Combined with biocompatible materials, it ensures sampling reliability while maximizing the safety and comfort of wearing the product.

[0045] This invention utilizes highly hydrophilic and low-cost hydrophilic materials to achieve tear drainage and collection, and combines them with sensing electrodes integrated on their surface to form an integrated drainage-detection structure. This greatly simplifies the equipment configuration and process, has significant cost advantages and is suitable for single use, avoids the risk of cross-infection, and eliminates the need for complex cleaning and disinfection processes, thus improving the convenience and hygiene safety of tear collection operations.

[0046] This invention integrates a tear component sensing unit for detecting tear biomarkers and a physical parameter sensing unit for detecting the physical state of the ocular surface onto the same substrate and shares a capillary drainage structure. This enables the simultaneous acquisition of two key types of information, chemical composition and physical parameters, during device use, thereby providing a multi-dimensional data foundation for the comprehensive assessment of ocular surface health and realizing non-invasive dynamic monitoring of ocular surface diseases. Attached Figure Description

[0047] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other embodiments can be obtained based on these drawings.

[0048] Figure 1An explosion diagram of a non-invasive tear analysis device according to one embodiment of this specification is shown;

[0049] Figure 2 It shows Figure 1 Top view of the non-invasive tear analysis device shown;

[0050] Figure 3 The following is a graph showing the electrical signal curves of the ion sensing electrode responding to tears at different pH values ​​in one embodiment of this specification;

[0051] Figure 4 An explosion diagram of a non-invasive tear analysis device according to another embodiment of this specification is shown;

[0052] Figure 5 It shows Figure 4 Top view of the non-invasive tear analysis device shown;

[0053] Figure 6 An explosion diagram of a non-invasive tear analysis device according to yet another embodiment of this specification is shown;

[0054] Figure 7 It shows Figure 6 Top view of the non-invasive tear analysis device shown;

[0055] Wherein, 1-1 is the first package; 1-2 is the first physical parameter sensing unit; 1-201 is the sensing part of the first physical parameter sensing unit; 1-3 is the first tear fluid composition sensing unit; 1-4 is the first flexible drainage part; 1-5 is the first substrate; 1-6 is the first microchamber assembly; 1-601 is the first tear fluid storage pool; 1-602 is the first microchannel; 1-603 is the first tear fluid outflow hole; 2-1 is the second package; 2-2 is the second physical parameter sensing unit; 2-201 is the second physical parameter sensing unit. 1-2 is the sensing unit of the third physical parameter sensing unit; 2-3 is the second tear component sensing unit; 2-4 is the second capillary drainage structure; 2-5 is the second substrate; 3-1 is the third package; 3-2 is the third physical parameter sensing unit; 3-201 is the sensing unit of the third physical parameter sensing unit; 3-3 is the third tear component sensing unit; 3-4 is the third substrate; 3-5 is the second microchamber assembly; 3-501 is the second tear reservoir; 3-502 is the second microchannel; 3-503 is the tear collection hole; 3-6 is the second tear outflow hole. Detailed Implementation

[0056] The features and exemplary embodiments of various aspects of the present invention will now be described in detail. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention may be practiced without requiring some of these specific details. The following description of embodiments is merely intended to provide a better understanding of the invention by illustrating examples of the invention.

[0057] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0058] In existing technologies, sensors used to monitor tear composition on the ocular surface often embed color or fluorescence probes into corneal contact lenses, which leads to problems such as low wearing comfort and potential interference with the ocular surface's physiological environment. Furthermore, corneal contact lens systems based on electrochemical sensing typically require the sensing electrodes to directly contact the tear film, potentially affecting visual quality and long-term biocompatibility. In addition, common clinical tear composition detection still relies on physicians collecting samples using tools such as capillaries for in vitro analysis, which is inconvenient and makes real-time, continuous monitoring difficult.

[0059] Example 1

[0060] This application discloses a non-invasive tear analysis device for comprehensive assessment of ocular surface health, including a substrate, a capillary drainage structure, a tear component sensing unit, a physical parameter sensing unit, and a package.

[0061] Specifically, the capillary drainage structure is set on the substrate to non-invasively collect and guide tears from the ocular surface through capillary action;

[0062] The tear component sensing unit is disposed on the substrate and is in fluid communication with the capillary drainage structure, and is used to detect at least one target chemical component in the tear.

[0063] The physical parameter sensing unit is disposed on the substrate and is used to detect at least one physical parameter of the ocular surface.

[0064] The encapsulation is connected to the substrate and is used to encapsulate and protect the capillary drainage structure tear component sensing unit and the physical parameter sensing unit disposed on the substrate.

[0065] In some embodiments, the target chemical components detected by the tear composition sensing unit include, but are not limited to, one or more of hydrogen ions, sodium ions, potassium ions, chloride ions, glucose, lactic acid, and specific proteins.

[0066] In some embodiments, the physical parameters detected by the physical parameter sensing unit include, but are not limited to, one or more of temperature, humidity, tear film stability, and ocular surface pressure.

[0067] In this embodiment, through the capillary action of the capillary drainage structure, a small amount of tear fluid can be actively and continuously drawn from the ocular surface without relying on external pumping, and guided to a preset detection area. The tear fluid component sensing unit comes into contact with the tear fluid and generates an electrochemical signal related to the concentration of specific chemical components. At the same time, the physical parameter sensing unit senses the physical parameters of the ocular surface directly or through a medium, and converts its changes into measurable electrical signals. The above signals are collected, processed and analyzed by an external circuit with a wired or wireless connection, thereby realizing synchronous real-time monitoring of the biochemical components of tear fluid and the physical environment of the ocular surface, providing multidimensional data for comprehensive assessment of ocular surface health.

[0068] Example 2

[0069] like Figures 1-2 As shown, this embodiment provides a specific implementation of Embodiment 1, specifically an external hook-type non-invasive tear analysis device, including a first substrate 1-5, a first capillary drainage structure, a first tear component sensing unit 1-3, a first physical parameter sensing unit 1-2, and a first package 1-1.

[0070] For example, the first capillary drainage structure includes a first flexible drainage portion 1-4 and two symmetrically arranged first microchamber assemblies 1-6.

[0071] Specifically, the first flexible drainage part 1-4 includes multiple parallel tubing, the inlet ends of the multiple tubing together forming a contact surface adapted to the eyelid contour, so as to contact the ocular surface to collect tears;

[0072] Specifically, each of the first microchamber assemblies 1-6 includes a first tear fluid storage pool 1-601, a first microchannel 1-602, and a first tear fluid outflow hole 1-603. The inlet end of the first tear fluid storage pool 1-601 is connected to the outlet end of the first flexible drainage part 1-4, the outlet end of the first tear fluid storage pool 1-601 is connected to the inlet end of the first microchannel 1-602, and the outlet end of the first microchannel 1-602 is connected to the inlet end of the first tear fluid outflow hole 1-603.

[0073] In the first flexible drainage section 1-4, multiple flexible tubes are divided into two groups to correspond to two first tear fluid storage pools 1-601 respectively; the outlet end of each group of tubes is evenly distributed along the top of the corresponding first tear fluid storage pool 1-601 to achieve uniform and independent flow of tears into each first tear fluid storage pool 1-601.

[0074] It should be understood that the specific implementation of the first capillary drainage structure is not limited thereto, and the number, shape, pore size and arrangement of the first micro-chamber components 1-6 can be adjusted according to actual needs.

[0075] In this embodiment, when a certain amount of tear fluid accumulates in the first tear fluid storage pool 1-601, the tear fluid component sensing unit starts to work, and the tear fluid sample that has been tested can continue to flow out through the first microchannel 1-602 and be replenished by new tear fluid, thereby ensuring the continuous updating of the tested sample.

[0076] In some embodiments, the first substrate 1-5 is made of a biocompatible flexible material, and the main body is a disk with a diameter of about 20 mm and a thickness of about 0.5 mm; the surface of the first substrate 1-5 can be formed by a soft photolithography process to form the first tear fluid storage pool 1-601, the first microchannel 1-602 and the first tear fluid outflow hole 1-603; the first package 1-1 is made of a transparent material, with an overall outer diameter of about 20 mm and a thickness of about 0.04 mm.

[0077] The materials used in the first substrate 1-5 and the first encapsulation component 1-1 include, but are not limited to, flexible biocompatible materials such as PDMS, PVC, and hydrogel, and their thickness can be adjusted according to actual needs. In this embodiment, the overall size of the analysis device, the thickness of the first substrate 1-5, the thickness of the first encapsulation component 1-1, and other parameters can be adaptively changed according to the application scenario.

[0078] Specifically, the first tear fluid storage pool 1-601 has a semi-fan-shaped structure with a thickness of approximately 140µm and a volume of approximately 4~6µl; the first microchannel 1-602 adopts a serpentine meandering structure with a depth of approximately 140µm and a width of approximately 175µm; and the diameter of the first tear fluid outflow hole 1-603 is approximately 0.4mm.

[0079] In this embodiment, the first package 1-1, as the top cover, is combined with the first base 1-5, which serves as the base, to encapsulate the first capillary drainage structure, the first tear fluid component sensing unit 1-3, and the first physical parameter sensing unit 1-2 inside, forming a sealed and complete device structure and protecting the sensing electrodes.

[0080] In some embodiments, the first physical parameter sensing unit 1-2 includes a temperature sensing element.

[0081] Specifically, the sensing part 1-201 of the first physical parameter sensing unit is arranged in a serpentine winding structure in the bending section of the first flexible drainage part 1-4; when the analysis device is used, the sensing part 1-201 of the first physical parameter sensing unit is made to fit closely to the contour of the ocular surface, thereby realizing accurate perception of physical parameters such as ocular surface temperature.

[0082] The serpentine winding structure is composed of multiple forward and reverse spliced ​​semicircular arcs, with an inner diameter of approximately 300µm.

[0083] It should be understood that the arrangement of the sensing units 1-201 of the first physical parameter sensing unit is not limited to a serpentine arrangement. The specific arrangement direction and the number of sensors can be increased, decreased or rearranged according to the detection requirements.

[0084] In some embodiments, the first tear component sensing unit 1-3 is an ion sensing electrode.

[0085] At least a portion of the ion sensing electrode is disposed within the first tear fluid storage pool 1-601. The ion sensing electrode is elongated in shape, and the sensing portion is approximately 2mm × 4mm in size.

[0086] The size, shape, and number of ion sensing electrodes can be changed according to the actual device structure requirements.

[0087] Specifically, the substrate of the ion sensing electrode is a conductive material, and silver / silver chloride paste, electrode paste, and insulating paste are sequentially printed using a screen printing process to form the electrode pattern. At the same time, a PEDOT:PSS film is deposited on the surface of the ion sensing electrode to improve electrode stability and prevent potential drift. In addition, the electrode surface can be modified by coating with an ion-selective permeable membrane solution and a PVB-coated Ag / AgCl solution to detect the concentration of hydrogen ions, sodium ions, etc.

[0088] The electrode materials used in the first tear component sensing unit 1-3 are not limited to those mentioned above, but may include highly biocompatible conductive materials such as graphene and multi-walled carbon nanotubes; the arrangement of the first tear component sensing unit 1-3 is not limited to being set along the first microchamber assembly 1-6, and can be adjusted to other arrangements according to actual needs.

[0089] In this embodiment, the working electrode, counter electrode, and reference electrode all have extended electrode leads. The sensing part of each electrode is arranged at the bottom of the first tear storage pool 1-601, and the electrode leads of each electrode are led out from the sensing part and arranged in parallel with the leads of the first physical parameter sensing unit 1-2. Finally, they all converge on the first substrate 1-5 to form a unified output interface, which is convenient for connection with an external signal receiving device.

[0090] When the first physical parameter sensing unit 1-2 comes into contact with the ocular surface, taking the temperature sensor as an example, the temperature sensor starts to work after adapting to the ocular surface environment. Its resistance value will change with the change of ocular surface temperature, and the change of conductivity will show a linear trend within a certain range. The change of conductivity can be received and recorded by an external signal receiving device, thereby achieving the purpose of monitoring the change of ocular surface temperature.

[0091] like Figure 3 As shown, when tears flow through and cover the ion sensing electrode area, the change in the concentration of the ion to be measured will cause a change in the open-circuit potential between the working electrode and the reference electrode. The value of this potential is linearly related to the logarithm of the ion concentration within a certain range. The change in the value of this open-circuit potential can be received and recorded by an external signal receiving device. After processing, continuous monitoring of the concentration of a specific ion in tears can be achieved.

[0092] By acquiring and processing the above-mentioned open-circuit potential and conductivity signals, and combining them with the analysis of the human ocular surface condition, the tear fluid state and physical properties of the ocular surface can be obtained, thereby achieving the purpose of real-time monitoring.

[0093] The hook-type solution provided in this embodiment achieves pump-free, self-driven drainage of tears through the first flexible drainage part 1-4. The device can be placed on the lower eyelid to complete the collection. The operation is simple and minimizes contact and interference with the ocular surface, avoiding the discomfort and inconvenience caused by traditional capillary collection methods.

[0094] Example 3

[0095] like Figures 4-5 As shown, this embodiment provides a specific implementation of Embodiment 1, specifically another external hook-type non-invasive tear analysis device, including a second substrate 2-5, a second capillary drainage structure 2-4, a second tear component sensing unit 2-3, a second physical parameter sensing unit 2-2, and a second encapsulation component 2-1.

[0096] The main difference between this embodiment and embodiment 2 is that the second capillary drainage structure 2-4 in this embodiment adopts an integrated design.

[0097] For example, the second capillary drainage structure 2-4 is made of a single piece of hydrophilic material. A portion of the hydrophilic material is bent or molded to directly form a second flexible drainage part for contacting and collecting tears, while another portion of the hydrophilic material is laid flat and attached to the second substrate 2-5.

[0098] The hydrophilic material can be Whatman filter paper or hydrophilic polymer film, or other materials with excellent capillary properties can be selected according to requirements; at the same time, the specific shape of the second flexible drainage part can be adjusted according to actual needs.

[0099] The hydrophilic material is approximately 35mm long, 5mm wide, and 0.1mm-0.2mm thick. It can also have graduations on its surface to help indicate and detect tear secretion. The size and thickness of the hydrophilic material can be adjusted according to the specific application scenario.

[0100] In some embodiments, the second substrate 2-5 is made of PET (polyethylene terephthalate) or PDMS, and is mainly cuboid with a length of approximately 25-30 mm, a width of 6-15 mm, and a thickness of approximately 0.05 mm-3 mm; the second encapsulation 2-1 is made of PDMS or PVC material, and its shape and size match the second substrate 2-5, with a thickness of approximately 0.05 mm-3 mm; the second encapsulation 2-1 and the second substrate 2-5 are combined to form a sealed space to protect the second capillary drainage structure 2-4, the second tear component sensing unit 2-3, and the second physical parameter sensing unit 2-2;

[0101] The materials used in the first substrate 1-5 and the first encapsulation are, but are not limited to, flexible biocompatible materials such as PDMS, PVC, and hydrogel, and their thickness can be adjusted according to actual needs. In this embodiment, the overall size of the analytical device, the thickness of the first substrate 1-5, the thickness of the first encapsulation, and other parameters can be adapted to the application scenario. The size of the sealed space can be adjusted according to the thickness of the hydrophilic material.

[0102] In some embodiments, the sensing part 2-201 of the second physical parameter sensing unit is attached to the surface of the bending area corresponding to the second flexible drainage part in a serpentine winding structure. When the device is in use, the sensing part is made to fit tightly against the contour of the ocular surface, thereby achieving accurate sensing of physical parameters such as ocular surface temperature.

[0103] The serpentine winding structure consists of multiple forward and reverse spliced ​​semicircular arcs, with an inner diameter of approximately 300µm-3000µm and a total width of approximately 4-4.5mm for the sensing part.

[0104] It should be understood that the arrangement of the sensing part 2-201 of the second physical parameter sensing unit is not limited to a serpentine arrangement. Its specific arrangement direction and the number of sensors can be increased, decreased or rearranged according to the detection requirements.

[0105] In some embodiments, the second tear component sensing unit 2-3 is an ion sensing electrode.

[0106] The electrodes of the second tear component sensing unit 2-3 can be directly fabricated on the surface of the hydrophilic material through processes such as screen printing or electrodeposition.

[0107] In this embodiment, by integrating the drainage portion and the microcavity structure into a single material sheet, the separate assembly of the tubing and microchannel substrate as in Embodiment 2 is eliminated, significantly simplifying the manufacturing and assembly process and improving device consistency. Furthermore, by integrating the ion-sensing electrodes onto the surface of the hydrophilic substrate, the device becomes thinner and smaller in size.

[0108] The hydrophilic-based solution in this embodiment utilizes highly hydrophilic and low-cost materials to achieve tear drainage and collection. Combined with the sensing electrodes integrated on its surface, it forms an integrated drainage-detection structure, which greatly simplifies the device configuration and process. It has significant cost advantages and is suitable for single use. While ensuring the detection function, it improves the convenience of operation and hygiene safety.

[0109] Example 4

[0110] like Figures 6-7 As shown, this embodiment provides another specific implementation of Embodiment 1, specifically a corneal contact lens type non-invasive tear analysis device, including a third base 3-4, a third capillary drainage structure, a third tear component sensing unit 3-3, a third physical parameter sensing unit 3-2, and a third package 3-1.

[0111] The main difference between this embodiment and embodiment 2 is that the third substrate 3-4 is in the form of a corneal contact lens, so that the non-invasive tear analysis device can be directly worn on the surface of the eyeball for tear collection and analysis.

[0112] For example, the third capillary drainage structure includes a second tear discharge orifice 3-6 and two symmetrically arranged second microchamber assemblies 3-5.

[0113] Specifically, each of the second microchamber components 3-5 includes a second microchannel 3-502, a second tear reservoir 3-501, and a plurality of tear collection holes 3-503.

[0114] The plurality of tear collection holes 3-503 are disposed through the lens body and are connected to the second tear storage pool 3-501, for collecting tears from the ocular surface by capillary action.

[0115] The inlet end of the second microchannel 3-502 is connected to the outlet end of the second tear storage pool 3-501, and the outlet end of the second microchannel 3-502 is connected to the inlet end of the second tear outflow hole 3-6.

[0116] The plurality of tear collection holes 3-503 are evenly distributed along the outer periphery of the second tear storage pool 3-501 to achieve uniform flow of tears into the second tear storage pool 3-501.

[0117] In some embodiments, the corneal contact lens is made of PDMS material, and the third substrate 3-4 is a disc with a diameter of approximately 14 mm and a thickness of approximately 0.05 mm. The third encapsulation component 3-1 is made of PDMS material or PVC material, and its shape and size match those of the third substrate 3-4, with a thickness of approximately 0.04 mm.

[0118] Specifically, the second tear storage pool 3-501, the second microchannel 3-502, the second tear outflow hole 3-6, and the tear collection hole 3-503 are formed on the third substrate 3-4 by soft photolithography.

[0119] The second tear fluid storage pool 3-501 has a semi-fan-shaped structure with a thickness of approximately 140µm and a volume of approximately 4-6µl. The second microchannel 3-502 adopts a serpentine, meandering structure with a depth of approximately 140µm and a width of approximately 175µm. The diameter of the second tear fluid outflow orifice 3-6 is approximately 1mm. The diameter of the tear fluid collection orifice 3-503 is approximately 400µm.

[0120] In this embodiment, the number, shape, and aperture of the tear collection holes 3-503, as well as the overall arrangement of the second microchamber assembly 3-5, can be adjusted according to actual fluid dynamics requirements and wearing comfort.

[0121] In this embodiment, the third encapsulation component 3-1 is combined with the third base 3-4 as a base to encapsulate the third capillary drainage structure, the third tear fluid component sensing unit 3-3 and the third physical parameter sensing unit 3-2 inside, forming a sealed and complete device structure, while also protecting the sensing electrodes.

[0122] In some embodiments, the third physical parameter sensing unit 3-2 includes a temperature sensing element.

[0123] Specifically, the sensing part 3-201 of the third physical parameter sensing unit is arranged in a ring shape, and its overall outer diameter is about 11.5 mm; the ring sensing part is attached to the surface of the third substrate 3-4 in a serpentine winding structure.

[0124] The serpentine winding structure is composed of multiple forward and reverse spliced ​​semicircular arcs, with an inner diameter of approximately 600µm.

[0125] It should be understood that the annular arrangement of the sensing part 3-201 of the third physical parameter sensing unit, the specific dimensions of the serpentine structure, and the number of sensors can be optimized according to the available area of ​​the non-optical area and the detection sensitivity requirements, and the arrangement direction can also be adjusted.

[0126] In some embodiments, the third tear component sensing unit 3-3 is an ion sensing electrode, and the sensing part of the ion sensing electrode is arranged at the bottom of the second tear storage pool 3-501.

[0127] Specifically, the substrate of the ion sensing electrode is a conductive material. Silver / silver chloride paste, electrode paste, and insulating paste are sequentially printed using a screen printing process to form the electrode. Simultaneously, a PEDOT:PSS film is electrodeposited onto the electrode surface to improve stability and prevent potential drift. Furthermore, the electrode surface can be modified by coating with an ion-selective permeable membrane solution and a PVB-coated Ag / AgCl solution, respectively, for the detection of hydrogen ions, sodium ions, and other ions.

[0128] The electrode leads of the ion sensing electrode are led out from the sensing unit and arranged in parallel with the leads of the third physical parameter sensing unit 3-2. They eventually converge on the third substrate 3-4 to form a unified output interface, which facilitates connection with an external signal receiving device.

[0129] The output interface can be connected to various wired or wireless signal acquisition and transmission systems, such as mini Bluetooth or NFC modules, to achieve real-time remote monitoring of data.

[0130] In this embodiment, the third physical parameter sensing unit 3-2 and the third tear fluid component sensing unit 3-3 are both located in the non-optical area of ​​the lens to avoid interfering with the user's vision and provide the user with a comfortable visual experience without visual obstruction or color changes. At the same time, the third physical parameter sensing unit 3-2 and the third tear fluid component sensing unit 3-3 are both covered by the third substrate 3-4 and the third encapsulation member 3-1 to achieve physical isolation between the sensing units and the ocular surface, thereby effectively maintaining corneal environmental homeostasis.

[0131] The corneal contact lens solution in this embodiment uses highly biocompatible materials to completely encapsulate the sensing electrodes inside the device, achieving physical isolation between the sensing unit and the cornea. At the same time, all sensing units are arranged in the non-optical area of ​​the lens, completely avoiding obstruction of vision and visual interference. This ensures long-term monitoring function while guaranteeing wearing safety and visual comfort.

[0132] It should be emphasized that the technical solutions in Examples 1 to 4 can not only be used for monitoring the ocular surface and tear film status, but through adaptive adjustments, their principles and structures can also be applied to the detection of ions and physical properties of various body fluids required for the diagnosis or monitoring of other systemic diseases.

[0133] Example 5

[0134] This embodiment discloses an ocular surface health monitoring system, including:

[0135] The non-invasive tear analysis device as described in any of Examples 2, 3, or 4; and

[0136] The data processing terminal is communicatively connected to the non-invasive tear analysis device and is used to receive and process sensor data from the non-invasive tear analysis device to generate ocular surface health assessment results.

[0137] In this embodiment, a non-invasive tear analysis device and a data processing terminal are used. The non-invasive tear analysis device acquires real-time sensing data of the ocular surface. After receiving the real-time sensing data, the data processing terminal performs a series of preprocessing steps, such as decoding, filtering, and analog-to-digital conversion. Based on the calculation model pre-installed in the data processing terminal, the data is processed and analyzed to finally obtain quantitative or semi-quantitative results of tear component concentration and ocular surface physical parameters. The real-time sensing data of the ocular surface includes tear component data and ocular surface physical parameter data.

[0138] In some embodiments, the data processing terminal may be embodied as a portable processing terminal based on an embedded microcontroller, the software of which may be developed using tools such as IAR;

[0139] Specifically, after the portable processing terminal is powered on, the program initializes the microcontroller's I / O ports, timers, and ADC module. To achieve long-term, low-power operation, the terminal is set to low-power mode and periodically woken up by configuring a timer interrupt, for example, setting the wake-up period to 1 second. After each wake-up, the system starts the ADC to continuously sample signals from the sensing device, and then automatically returns to sleep mode.

[0140] After data collection is completed, the program performs mean filtering on multiple sets of data to suppress noise, and sends the processed results to the user's smart terminal in an agreed data format via wireless communication protocols such as Bluetooth.

[0141] In some embodiments, a dedicated application is configured on the user's smart terminal side to receive and parse data, converting the data into concentration values ​​and physical parameter values ​​with clear physical meaning.

[0142] Furthermore, the application can also enable local storage and management of data, and can display it in real time and provide historical data review in the form of charts.

[0143] It should be noted that the signal transmission between the non-invasive tear analysis device, the data processing terminal and the user's smart terminal in this embodiment can be carried out in various ways, including but not limited to wired workstation systems, Bluetooth signal transmission or NFC signal transmission.

[0144] In specific clinical application examples, the ocular surface health monitoring system described in this embodiment can provide key multidimensional parameters for the auxiliary diagnosis and assessment of dry eye syndrome.

[0145] Taking the dynamic monitoring of tear pH as an example: the pH of healthy tears is usually maintained at about 7.9, while the pH can drop to about 7.4 when the tear film breaks up. This change has important clinical implications. At the same time, the concentration of Na⁺ ions in tears is also one of the key indicators. In healthy people, it is generally 120–165 mmol / L, while in patients with dry eye caused by meibomian gland dysfunction or abnormal tear secretion, this concentration is often significantly elevated.

[0146] This embodiment can also continuously monitor ocular surface temperature and its changing trend; for example, the decrease in corneal temperature is significantly correlated with tear film breakup time, and the decrease in ocular surface temperature in patients with dry eye syndrome is usually greater than that in normal people after 10 seconds of eye exposure.

[0147] This embodiment utilizes the aforementioned non-invasive tear analysis device to indirectly assess tear secretion through capillary drainage structures, thereby performing functional tests similar to traditional tear secretion experiments. Ultimately, by comprehensively processing and analyzing multiple characteristic signals such as tear volume, specific ion concentration, ocular surface temperature, and its dynamic change rate, it can efficiently and conveniently provide quantitative diagnostic evidence and personalized assessment plans for clinical use. It can not only be used for disease screening and auxiliary diagnosis but also guide patients' subsequent medical treatment and provide support for long-term efficacy monitoring.

[0148] Example 6

[0149] This embodiment discloses a method for using a non-invasive tear analysis device, applicable to the non-invasive tear analysis device described in either Embodiment 2 or 3 above, including:

[0150] The curved part of the flexible drainage section of the non-invasive tear analysis device is attached to the lower edge of the tear duct of the user's lower eyelid to ensure that its inlet end is in contact with the tear fluid on the ocular surface.

[0151] After the device is fixed, the flexible drainage part continuously draws and guides tears from the ocular surface;

[0152] When tears cover the first tear component sensing unit, an electrochemical signal related to the concentration of the target chemical component in the tears is generated.

[0153] The physical state of the ocular surface is sensed by the first physical parameter sensing unit, and a corresponding physical signal is generated.

[0154] The unified output interface of the non-invasive tear analysis device is connected to an external signal receiving device to output the first electrochemical signal and the first physical signal.

[0155] After completing the preset monitoring cycle, remove the device to complete the monitoring.

[0156] In some embodiments, the device can be kept stable in any of the following ways to maintain stable contact between the flexible drainage portion and the ocular surface:

[0157] Wear and secure the device near the eyes on your face;

[0158] Hold and stably support the device;

[0159] Alternatively, medical tape can be used to gently fix the main body of the device to the area around the eyes and face.

[0160] Example 7

[0161] This embodiment discloses a method for using a non-invasive tear analysis device, applied to the non-invasive tear analysis device described in Embodiment 4 above, including:

[0162] Provided that the user's ocular surface condition permits, the non-invasive tear analysis device is worn on the surface of the user's eyeball in the manner of wearing a regular contact lens, ensuring that its third base adheres to the cornea and that the tear collection pore is connected to the tear layer on the ocular surface.

[0163] After being worn, the tear fluid is continuously drawn from the ocular surface tear film through the tear collection hole by the capillary action of the third capillary drainage structure and guided to the second tear storage pool.

[0164] When the tear fluid in the second tear fluid storage pool covers the first tear fluid component sensing unit, an electrochemical signal related to the concentration of the target chemical component in the tear fluid is generated.

[0165] The physical state of the ocular surface is sensed by the first physical parameter sensing unit, and a corresponding physical signal is generated.

[0166] The unified output interface of the non-invasive tear analysis device is connected to an external signal receiving device to output the electrochemical and physical signals;

[0167] After completing the preset monitoring cycle, remove the device to complete the monitoring.

[0168] In summary, this embodiment achieves non-invasive intervention on the ocular surface through a hook-type and corneal contact lens-type structural design, utilizes capillary action to achieve autonomous tear drainage, avoids external active absorption or physical scraping, and combines biocompatible materials to ensure sampling reliability while maximizing the safety and comfort of wearing.

[0169] The different device forms provided in this embodiment can adapt to diverse clinical and research needs, from rapid outpatient testing to long-term continuous monitoring. They not only provide objective evidence for the diagnosis, classification, and efficacy evaluation of ocular surface diseases such as dry eye, but also provide a reference for the auxiliary diagnosis of related systemic diseases, and have broad clinical application prospects and sustainable development potential.

[0170] The above description is merely a preferred embodiment of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects. The scope of the present invention is defined by the appended claims rather than the foregoing description, and thus all variations falling within the meaning and scope of the equivalents of the claims are intended to be included within the present invention.

Claims

1. A non-invasive tear analysis device for comprehensive assessment of ocular surface health, characterized in that, The device is an external device, comprising: a substrate; a capillary drainage structure disposed on the substrate for collecting and guiding tear fluid from the ocular surface by capillary action; a tear component sensing unit disposed on the substrate in fluid communication with the capillary drainage structure for detecting at least one chemical component in the guided tear fluid; a physical parameter sensing unit disposed on the substrate for detecting at least one physical parameter of the ocular surface; an encapsulating member connected with the substrate for encapsulating the structures on the substrate; the capillary drainage structure comprises a flexible drainage portion disposed on the substrate, one end of the flexible drainage portion being used for contacting and collecting tear fluid at the ocular surface.

2. The apparatus of claim 1, wherein, The capillary drainage structure is composed of a hydrophilic base material; at least a part of the hydrophilic base material is bent to form the flexible drainage portion; the electrodes of the tear component sensing unit are disposed on the surface of the hydrophilic base material.

3. The apparatus of claim 1, wherein, The capillary drainage structure comprises at least one first micro-chamber assembly; the first micro-chamber assembly comprises a first micro-channel, a first tear fluid outlet hole and a first tear fluid storage pool; the liquid inlet end of the first tear fluid storage pool is connected with the flexible drainage portion, and the liquid outlet end of the first tear fluid storage pool is sequentially connected with the first micro-channel and the liquid inlet end of the first tear fluid outlet hole; at least part of the electrodes of the tear component sensing unit is disposed in the first tear fluid storage pool.

4. The apparatus of claim 2 or 3, wherein, The sensing part of the physical parameter sensing unit is arranged in the bending section of the flexible drainage portion to be close to the ocular surface in use; the lead of the physical parameter sensing unit is disposed adjacent to the electrode lead of the tear component sensing unit.

5. The apparatus of any one of claims 1-4, wherein, The tear component sensing unit is an ion sensing electrode; the ion sensing electrode comprises a working electrode, a counter electrode and a reference electrode, and the working electrode is located between the counter electrode and the reference electrode.

6. A non-invasive tear analysis device for comprehensive assessment of ocular surface health, characterized in that, The device is a contact lens device, comprising: a substrate, which is a contact lens; a capillary drainage structure disposed in the substrate for collecting and guiding tear fluid from the ocular surface by capillary action; a tear component sensing unit disposed on the substrate in fluid communication with the capillary drainage structure for detecting at least one chemical component in the guided tear fluid; a physical parameter sensing unit disposed on the substrate for detecting at least one physical parameter of the ocular surface; an encapsulating member connected with the substrate for encapsulating the structures on the substrate.

7. The apparatus of claim 6, wherein, The capillary drainage structure comprises a second tear fluid outlet hole and at least one second micro-chamber assembly; the second micro-chamber assembly comprises a second micro-channel, a second tear fluid storage pool and at least one tear fluid collection hole; the tear fluid collection hole is disposed through the lens body and is in communication with the second tear fluid storage pool for collecting tear fluid from the ocular surface by capillary action; the liquid inlet end of the second micro-channel is connected with the liquid outlet end of the second tear fluid storage pool, and the liquid outlet end of the second micro-channel is connected with the liquid inlet end of the second tear fluid outlet hole; at least part of the electrodes of the tear component sensing unit is disposed in the second tear fluid storage pool.

8. The apparatus of claim 7, wherein, The sensing part of the physical parameter sensing unit is arranged in the bending section of the flexible drainage portion to be close to the ocular surface in use; the lead of the physical parameter sensing unit is disposed adjacent to the electrode lead of the tear component sensing unit. The tear component sensing unit is an ion sensing electrode; the ion sensing electrode comprises a working electrode, a counter electrode and a reference electrode, and the working electrode is located between the counter electrode and the reference electrode. The lead of the physical parameter sensing unit is arranged adjacent to the electrode lead of the tear component sensing unit.

9. The apparatus of any one of claims 6-8, wherein, The sensing electrode of the tear component sensing unit is arranged in the non-optical zone of the lens; The tear component sensing unit is an ion sensing electrode; the ion sensing electrode comprises a working electrode, a counter electrode and a reference electrode, and the working electrode is located between the counter electrode and the reference electrode.

10. An ocular surface health comprehensive assessment system, comprising: Comprising: The non-invasive tear analysis device of any one of claims 1 to 5, or The non-invasive tear analysis device of any one of claims 6 to 9; and A data processing terminal, which is communicatively connected with the non-invasive tear analysis device, is used for receiving and processing the sensing data from the non-invasive tear analysis device to generate an ocular surface health assessment result.

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