Contact liquid supplementing multi-angle corneal ultraviolet crosslinking irradiation head

Abstract

The application relates to the technical field of ophthalmic medical instruments, and discloses a contact type liquid supplementing multi-angle corneal ultraviolet crosslinking irradiation head which comprises a support structure extremely close contact non-stress support structure which is arranged around the periphery of an ultraviolet light transmission irradiation window and is attached to the periphery of a cornea to maintain the relative position stable; the ultraviolet light transmission irradiation window is used for transmitting UVA and observing the cornea; a microporous liquid supplementing structure is used for outputting liquid supplement to the surface of the cornea to maintain the moisture; a plurality of independently driven UVA light emitting units are integrated on the side, away from the cornea, of the irradiation window, wherein the light emitting directions of part of the light emitting units are non-perpendicular relative to the local surface of the cornea; and a partition driving interface receives external parameters to control the working states of the light emitting units. Through the cooperative design of the contact positioning, dynamic liquid supplementing and non-perpendicular partition irradiation, the contact type liquid supplementing multi-angle corneal ultraviolet crosslinking irradiation head solves the pain points of the positioning deviation of the existing non-contact crosslinking equipment, corneal dehydration and the high risk of endothelial injury in the thin cornea area, and can adapt to the individualized treatment requirements of scenarios such as keratoconus, refractive surgery combined crosslinking surgery and the like.

Description

Technical Field

[0001] This invention relates to the field of ophthalmic medical device technology, specifically to a contact-type fluid replenishment multi-angle corneal ultraviolet cross-linking irradiation head, which is suitable for corneal collagen cross-linking treatment of corneal ectasia diseases such as keratoconus and iatrogenic corneal ectasia, and can also be used in ophthalmic surgical scenarios such as refractive surgery combined with cross-linking and corneal ulcer reinforcement. Background Technology

[0002] Corneal collagen cross-linking is currently the core treatment method used clinically for corneal ectasia diseases such as keratoconus and iatrogenic corneal ectasia, and it is also a commonly used combined procedure with refractive corneal laser surgery. Its basic principle is to infiltrate riboflavin into the corneal tissue, and then use UVA (wavelength 365±10nm) ultraviolet light irradiation to induce cross-linking of corneal stromal collagen fibers, thereby enhancing the biomechanical strength of the cornea and preventing or stopping further corneal ectasia.

[0003] Existing technologies still suffer from the following insurmountable drawbacks:

[0004] 1. Poor positioning stability: Most existing cross-linking devices use non-contact irradiation, with the ultraviolet light source located 5-10cm above the cornea. Irradiation stability is affected by micro-movements of the eyeball, traction of the eyelid speculum, changes in the intraoperative fluid film, and equipment positioning errors, which can easily lead to irradiation deviation.

[0005] 2. Large fluctuations in corneal dehydration: Cross-linked irradiation lasts for several minutes to more than ten minutes, during which the cornea is continuously exposed to air, riboflavin, and UVA. Changes in surface humidity can lead to a decrease in corneal thickness and a change in curvature, which in turn causes fluctuations in UVA penetration depth and energy distribution, affecting treatment efficacy and repeatability.

[0006] 3. High risk of endothelial penetration in thin corneas: The weak areas of diseases such as keratoconus overlap with the thinnest areas. When traditional vertical irradiation increases the treatment energy in the weak areas, it increases the risk of UVA penetrating to the endothelial side, making it difficult to balance the needs of "sufficient energy in the disease area" and "endothelial safety in the thin area".

[0007] 4. Low degree of personalization: Existing equipment mostly uses a single large spot or vertical partition irradiation, which cannot match the morphological characteristics of irregular lesions in the local area, and is prone to overtreatment or undertreatment.

[0008] 5. Lack of integrated moisturizing design: Existing equipment does not have a dynamic fluid replenishment function during the procedure and can only maintain humidity by dripping medication before the procedure, which cannot solve the problem of dynamic dehydration during the irradiation process.

[0009] Although some studies have proposed personalized cross-linking concepts, such as the Avedro KXL-II system which can adjust the beam pattern using digital light projection, it still employs non-contact vertical irradiation, failing to resolve the aforementioned core contradiction. Currently, there is no corneal cross-linking irradiation head that simultaneously possesses contact positioning, dynamic fluid replenishment, and multi-point non-vertical light emission capabilities, necessitating a new equipment solution. Summary of the Invention

[0010] The technical problem to be solved by the present invention is to provide a contact-type fluid replenishment multi-angle corneal ultraviolet cross-linking irradiation head that addresses the above-mentioned deficiencies of the prior art by solving the above-mentioned problems through structural synergistic design, thereby achieving safe and precise cross-linking treatment.

[0011] The technical solution adopted by this invention to solve its technical problem is:

[0012] The technical solution adopted by this invention to solve its technical problem is as follows: A contact-type multi-angle corneal UV cross-linking irradiation head is constructed. A support structure surrounding the treatment area achieves stable adhesion between the irradiation head and the cornea through extremely close contact with a stress-free support structure, eliminating the influence of eyeball micro-movement, eyelid opener traction, and equipment alignment errors. A microporous fluid replenishment structure around the irradiation window maintains corneal surface moisture, reducing thickness fluctuations and UVA transmittance changes caused by dehydration. An integrated multi-point UVA light-emitting unit with independent driving circuits, combined with an oblique / low incident angle / near-tangential multi-angle light-emitting design, reduces the risk of UVA penetrating to the endothelium along the corneal thickness direction while ensuring sufficient energy in the lesion area. An optional drainage structure maintains uniform and stable fluid film, a light-shielding structure prevents scattered light from damaging medical personnel, and a zoned drive interface enables personalized and dynamic parameter adjustments.

[0013] Compared with the prior art, the present invention has the following beneficial effects:

[0014] 1. More stable positioning: By using a support structure that is in very close contact with a stress-free support structure, the working distance between the irradiation head and the cornea is reduced to ≤2mm, which greatly reduces the irradiation deviation caused by micro-movement of the eyeball and equipment alignment error, and the positioning accuracy is improved by more than 60% compared with non-contact equipment;

[0015] 2. Enhanced humidity control: Through the microporous liquid replenishment structure, the corneal surface is continuously or intermittently kept moist during UVA irradiation, and the fluctuation of corneal thickness is controlled within ±10μm, avoiding changes in UVA penetration depth and riboflavin concentration distribution caused by dehydration.

[0016] 3. Higher degree of personalized matching: Through multi-point UVA light-emitting units, different areas can be irradiated in different zones, which can match the lesion characteristics of corneal topography and thickness map, avoiding the defects of single large spot irradiation;

[0017] 4. Enhanced endothelial safety: Through the non-vertical emission design of at least some UVA emission units, more UVA energy is applied to the corneal stroma. Thin corneal areas require more energy while ensuring the safety of the corneal endothelium, thus resolving the contradiction between "sufficient energy in the diseased area" and "safety of the thin endothelium".

[0018] 5. Better treatment uniformity: The optional drainage structure maintains a stable thin liquid film, avoiding light scattering and refraction caused by liquid accumulation, and the uniformity of energy distribution is improved by more than 50% compared with non-contact devices;

[0019] 6. High scalability: Through the partition control interface, it can be connected to external corneal thickness, topographic maps or real-time imaging systems, providing a hardware foundation for the subsequent construction of a real-time feedback corneal cross-linking system. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the present invention will be further described below in conjunction with the accompanying drawings and embodiments. The drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort:

[0021] Figure 1 This is a schematic diagram of the overall structure of the contact-type multi-angle corneal ultraviolet cross-linking irradiation head according to an embodiment of the present invention;

[0022] Figure 2 Cross-sectional view of the contact / near contact between the irradiation head and the cornea in an embodiment of the present invention;

[0023] Figure 3 Schematic diagram of the microporous fluid replenishment structure of this invention embodiment;

[0024] Figure 4 Schematic diagram of the multi-point UVA light-emitting unit array and partitioning according to an embodiment of the present invention;

[0025] Figure 5 A schematic diagram of the multi-angle light emission protection area for thin cornea according to an embodiment of the present invention;

[0026] Figure 6 A schematic diagram illustrating the connection between the irradiation head and an external device according to an embodiment of the present invention;

[0027] Figure 7 A reference diagram of the three-dimensional structure of the contact-type fluid replenishment multi-angle corneal ultraviolet cross-linking irradiation head according to an embodiment of the present invention.

[0028] Figure labels: 1-Irradiation head body; 2-Support structure: near-contact, stress-free support structure (also known as flexible contact support); 3-UV light transmission window; 4-Microporous liquid outlet; 5-Replenishment inlet; 7-UVA light emission unit; 8-Vertical light emission direction; 9-Oblique light emission direction; 10-Near-tangential light emission direction; 12-Zone drive and external parameter input interface; 13-Corneal surface; 14-Corneal stroma; 15-Corneal endothelium; 16-Local thin corneal area; 17-Connecting and fixing structure. Zone labels: Zone A - Central zone; Zone B - Paracentral zone; Zone C - Peripheral zone. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, a clear and complete description will be provided below in conjunction with the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the protection scope of the present invention.

[0030] In this invention, the term "contact or near contact" refers to a distance of ≤2mm between the flexible support structure and the corneal surface, including direct contact or a near contact state with a gap of ≤1mm, completely eliminating the 5-10cm working distance of traditional non-contact devices; "non-perpendicular direction" refers to an angle ≥15° between the light direction and the local surface normal of the cornea, where low incident angle refers to an angle of 15°-45° and near tangential refers to an angle ≥75°; stable liquid film state refers to a liquid film thickness of 10-50μm on the corneal surface, without bubbles or local accumulation, and UVA transmittance fluctuation ≤3%.

[0031] Combination Figure 1-7 In this embodiment, the main body 1 of the contact-type multi-angle corneal ultraviolet cross-linking irradiation head is made of medical-grade polycarbonate (PC) material. It is cylindrical in shape, with a diameter of 12-15mm and a height of 8-10mm. The front end (close to the cornea) is equipped with a functional module, and the rear end is equipped with a connection and interface module. The spatial position and parameters of each component are as follows:

[0032] like Figure 2 As shown, the support structure is in very close contact with the stress-free support structure 2, which is coaxially arranged around the outer periphery of the ultraviolet light transmission window 3. It is made of medical-grade silicone with a Shore A hardness of 30±5, and has a light transmittance of ≥90% in the 400-700nm visible light band. The surface is smooth and without sharp corners. The difference between the radius of curvature of the front bonding surface and the radius of curvature of the anterior corneal surface is ≤0.5mm, which is suitable for the corneal curvature of most patients in clinical practice (7.8-8.2mm).

[0033] The preferred design is a shallow cup-shaped structure: with an inner diameter of 10mm, an outer diameter of 14mm, and a height of 2mm. It supports the sclera in the 0.5-1mm lateral limbus region, with an adhesion pressure of 2-5mmHg. This ensures balanced circumferential adhesion, eliminates the influence of micro-movements of the eyeball, and avoids compressing the central corneal lesion area. Other optional shapes include: a ring structure with a width of 2-3mm, an arc structure consisting of three equally divided 120° arc segments, and a dome-shaped structure with its bottom edge forming a ring-shaped adhesion surface. All of these are coaxially arranged with the illumination window 3, without obstructing the light path.

[0034] like Figure 1 , 2 As shown, the irradiation window 3 is a circular light-transmitting area in the center of the irradiation head, with a diameter of 6-8 mm, corresponding to the corneal pupil area and the lesion treatment area. It is made of quartz glass or cyclic olefin copolymer (COC) and has a transmittance of ≥95% for therapeutic 365nm UVA. The surface can be coated with one or more of the following functional coatings (total thickness 50-200 nm, prepared by vacuum evaporation / spin coating): a nano-hydrophilic coating: water contact angle <10°, preventing the formation of water droplets; a nano-anti-fog coating: transmittance decrease of <2% under saturated humidity; a perfluoroalkyl anti-riboflavin residue coating: riboflavin adhesion <0.1 μg / cm², facilitating surgical cleaning. The irradiation window 3 can be a planar structure (1 mm thick) or a curved structure adapted to the curvature of the cornea (curvature radius 8.0±0.2 mm, thickness 1.5 mm), allowing UVA to pass through and allowing the surgeon to directly observe the corneal surface condition.

[0035] like Figure 3 As shown, the microporous fluid replenishment structure is built into the body 1 of the irradiation head, and the parameters of the pipelines connected in sequence are as follows: Fluid replenishment inlet 5: located on the side of the irradiation head, adapted to a medical silicone tube with an outer diameter of 2mm, and connected to an external fluid replenishment pump; Annular fluid replenishment chamber: an annular tube with an inner diameter of 8mm and an outer diameter of 10mm, with a volume of 0.2mL, coaxial with the irradiation window 3 to ensure uniform fluid replenishment pressure;

[0036] Micro-replenishment channels: 6 channels evenly distributed circumferentially, with an inner diameter of 0.3 mm and a length of 2 mm, extending from the annular replenishment chamber to the irradiation window area; Micro-orifice outlets 4: a total of 12, with 2 outlets connected to the end of each channel, with an orifice diameter of 80±10 μm, evenly distributed within 1 mm of the periphery of the irradiation window 3, with a total replenishment flow rate of 0.1-0.5 mL / min and a flow rate deviation of <5% for each outlet.

[0037] The rehydration solution is 0.1% riboflavin phosphate solution (pH 7.2-7.4) or balanced salt solution (BSS). The rehydration method is continuous micro-infusion (0.1-0.5 mL / min) or intermittent rehydration (cycle 10-30 seconds, single rehydration 0.05-0.1 mL). The rehydration pressure is 10-20 cmH2O to avoid impacting the cornea.

[0038] like Figure 4 As shown, the UVA light-emitting unit 7 is integrated on the side of the irradiation window 3 away from the cornea, with a distance of 2-3mm between it and the irradiation window 3. Each unit corresponds to an independent constant current drive circuit (integrated on the PCB board inside the irradiation head, with a drive current accuracy of ±1% and a response time of <5ms).

[0039] Unit type: Miniature UVA LED (chip size 1×1mm, emission wavelength 365±5nm, half-width at half-maximum <10nm, optical power 0-5mW adjustable) is preferred. Alternatively, a quartz fiber optic output port with a core diameter of 200μm (numerical aperture 0.22, light uniformity >90%) or a microlens output port (quartz material, focal length 2-5mm, spot diameter 0.5-1mm) can be used.

[0040] Arrangement method: The preferred arrangement is a zoned arrangement, corresponding to the three treatment areas of the cornea: A (central area), B (paracentral area), and C (peripheral area). Area A consists of a 3×3 array with a total of 9 units, area B consists of a paracentral ring with a total of 8 units, and area C consists of a peripheral ring with a total of 8 units, for a total of 25 units. The unit spacing is 1.5mm, and the light spots do not overlap or have gaps. Array, sector, and honeycomb arrangements can also be used.

[0041] Non-perpendicular light emission is achieved by ensuring that the light emission direction of at least some units is not perpendicular to the local surface of the cornea. This is specifically adjusted in the following ways (angle error <2°): oblique light emission (angle 15°-45°): a quartz microprism is placed at the light emission port (refractive angle corresponding to 15°-45°); low incident angle light emission (angle 15°-45°): the fiber end face is ground into a bevel at the corresponding angle; near-tangential light emission (angle 75°-85°): the microprism refraction angle is 75°-85° or the fiber end face is ground into a bevel at 75°-85°.

[0042] like Figure 5 As shown, the UVA emitted vertically 8 (angle 0°) penetrates the entire corneal stroma 14 and may reach the endothelium 15; the UVA emitted obliquely 9 (angle 30°) penetrates to a depth of 2 / 3 of the corneal thickness; the UVA emitted near tangentially 10 (angle 80°) penetrates to a depth of only 1 / 2 of the corneal thickness, and the endothelium 15 of the thin corneal region 16 is almost not exposed to UVA.

[0043] like Figure 6 As shown, the partition drive and external parameter input interface 12 is located at the tail of the irradiation head. It adopts a CAN bus / USB2.0 / fiber interface, with a refresh rate of 10Hz. It can receive the following parameters sent by the host of the external crosslinking device: the optical power, switch status, irradiation time, pulse frequency, and light emission angle combination of each UVA unit. It can also be connected to the real-time feedback data of the corneal topography instrument, corneal pachymeter, and intraoperative OCT to dynamically adjust the irradiation parameters. The response time is <10ms.

[0044] like Figure 2 As shown, an annular drainage channel with a width of 0.5-1mm and a depth of 0.3-0.8mm is located at the bottom inner side of the flexible structure 2 and is connected to the drainage outlet; or a reflux channel with an inner diameter of 0.5mm and a micro negative pressure interface is used, with a negative pressure value of -5~-10mmHg, which only drains excess liquid and will not suck up the corneal epithelium, maintaining a stable liquid film thickness of 10-50μm.

[0045] like Figure 1 , 5 As shown, black medical-grade polyimide (0.2mm thick, with a 365nm UVA blocking rate of ≥99.9%) is used and placed 1-2mm outside the light emission path of the non-vertical light emission unit, extending 3-5mm along the light emission direction. This allows only the light in the treatment direction to be emitted, blocking scattered light to avoid damage to medical personnel.

[0046] like Figure 1 , 6 As shown, located in the middle of the outer periphery of the irradiation head, avoiding the central optical path area, it adopts any of the following methods: Snap-on connection: 1-2mm wide and 1mm deep annular slot, compatible with the corresponding snap of the eyelid opener, with a locking force of 0.5-1N; Magnetic connection: Neodymium iron boron magnet, magnetic force 0.5-1N, positioning accuracy <0.1mm, compatible with surgical robotic arms; Disposable sterile interface: Medical-grade PE material, sterile packaging, disposable after use to avoid cross-infection.

[0047] The following describes the workflow and effects of this invention in detail using four typical clinical scenarios:

[0048] Example 1: Keratoconus Cross-linking Treatment

[0049] Applicable scenarios: Patients with keratoconus, with the central A zone being the thinnest lesion area (380μm), the paracentral B zone being 420μm thick, the peripheral C zone being 480μm thick, and the posterior surface high-abnormal area located in the central A zone, requiring a balance between treatment energy and endothelial safety.

[0050] In this implementation, the specific parameters of each functional module are as follows:

[0051] The support structure is in very close contact and is not subject to stress. Support structure 2 is made of medical-grade silicone with a Shore A hardness of 30±5 and a shallow cup shape with a curvature radius of 8.0mm, which is adapted to the patient's corneal curvature of 8.1mm. It is supported on the outer side of the corneal limbus with a contact pressure of 3mmHg and does not compress the central lesion area.

[0052] The UV irradiation window 3 is a curved structure made of quartz glass with a diameter of 7 mm and a radius of curvature of 8.0 mm. The surface is coated with a 100 nm thick anti-riboflavin residue coating, and the transmittance of 365 nm UVA is ≥95%. The microporous liquid replenishment structure has a total of 12 microporous liquid outlets with a pore size of 80 μm, distributed within a 1 mm range around the irradiation window. The liquid replenishment flow rate is 0.2 mL / min, and the liquid replenishment is 0.1% riboflavin phosphate solution. The flow rate deviation of each liquid outlet is <5%.

[0053] The UVA light-emitting unit 7 comprises 25 units in total. Among them, 9 units in the central A area are vertically emitting (0° angle), and 16 units in the peripheral B area and C area are near-tangentially emitting (80° angle). The wavelength is 365±5nm, and the optical power density is 3mW / cm² in the A area and 1.5mW / cm² in the B / C areas. Each unit corresponds to an independent constant current drive circuit with a drive current accuracy of ±1%.

[0054] The drainage structure uses an annular drainage trough with a width of 0.8 mm and a depth of 0.5 mm, located at the bottom of the inner side of the flexible structure, and excess liquid is discharged into the waste liquid collection bag;

[0055] The light-shielding structure uses a 0.2mm thick black medical-grade polyimide sheet, which is placed 1-2mm outside the light emission path of the near-tangential light-emitting unit in the B / C area, and has a blocking rate of ≥99.9% for 365nm UVA.

[0056] The connecting and fixing structure 17 adopts a snap-on type, which is compatible with conventional eyelid openers and has a locking force of 0.8N; the partition drive and external parameter input interface 12 adopts a CAN bus interface with a refresh rate of 10Hz, which can receive preoperative corneal topography parameters.

[0057] Detailed workflow:

[0058] Preoperative preparation: After sterilization, the irradiation head is installed on the eyelid opener with a snap fastener. Connect the infusion tube, drainage tube, and data cable. Prefill the microporous infusion structure with riboflavin solution for 2 seconds, expel air from the tubing, and confirm that the light output of each unit is normal.

[0059] Intraoperative positioning: The eyelid speculum opens the eyelid to expose the cornea. The irradiation head is slowly moved down so that the flexible structure 2 is gently attached to the outer side of the corneal limbus. The downward pressure is 0.5 mm and the attachment pressure is 3 mmHg. It is confirmed that the irradiation window 3 is aligned with the center of the cornea without deviation.

[0060] Infusion start-up: Start the micro infusion pump and continuously output riboflavin solution at 0.2 mL / min. After 10 seconds, a stable liquid film of 10-30 μm is formed on the corneal surface. No bubbles or accumulation can be observed through the irradiation window. Excess liquid is discharged simultaneously from the drainage tank, and the thickness of the liquid film remains stable.

[0061] Irradiation therapy: External equipment controls each unit based on preoperative topographic map parameters.

[0062] Vertical light-emitting unit in area A: 3mW / cm² irradiation for 5 minutes, cumulative energy 9J / cm²;

[0063] Near-tangential light-emitting unit in zones B / C: Irradiation for 8 minutes at 1.5mW / cm², cumulative energy 7.2J / cm²; parameters are refreshed every 10ms during irradiation, energy fluctuation <1%.

[0064] Postoperative care: After irradiation, stop fluid infusion and light emission, remove the irradiation head, rinse the corneal surface with BSS, and the treatment is complete.

[0065] Efficacy verification: During the treatment, the irradiation head deviation was <0.3mm, the corneal thickness fluctuation was <7μm, the cumulative endothelial UVA dose was 0.28J / cm² (below the safety threshold of 0.35J / cm²), and the corneal curvature stabilized 6 months postoperatively, with a 3.2% decrease in endothelial cell density, which met clinical expectations.

[0066] Example 2: Treatment of Iatrogenic Corneal Elongation After LASIK Surgery

[0067] Applicable scenario: LASIK surgery corneal ectasia, the ectasia area is located in the temporal B zone, and the central A zone is the corneal flap area (thickness 450μm), which requires targeted strengthening of the ectasia area treatment.

[0068] In this implementation, the specific parameters of each functional module are as follows:

[0069] The support structure, in close contact and without stress, consists of a ring-shaped structure made of transparent polymer material, 2.5 mm wide, adapted to the surgical corneal shape, supporting the outer side of the corneal limbus with a contact pressure of 2 mmHg. The ultraviolet light transmission window 3 is a planar structure made of cyclic olefin copolymer (COC), 7 mm in diameter, with a nano-hydrophilic coating on the surface, a water contact angle <10°, and a transmittance of ≥95% for 365 nm UVA. The microporous fluid replenishment structure has 12 microporous outlets with a pore size of 80 μm, distributed inside the flexible contact structure. Fluid replenishment is intermittent, with a cycle of 20 seconds, a single replenishment volume of 0.08 mL, and a 0.1% riboflavin solution. The flow rate deviation of each outlet is <5%. There are 25 UVA light-emitting units 7 arranged in a sector-like pattern, with the temporal side... Eight units in area B emit light obliquely (30° angle), nine units in central area A emit light vertically (0° angle), and eight units in peripheral area C emit light vertically (0° angle). The wavelength is 365±5nm. The light power density is 4mW / cm² in the temporal area B and 3mW / cm² in the remaining areas. Each unit has an independent constant current drive circuit. The drainage structure uses a reflux channel and a micro negative pressure interface, with the negative pressure value set to -8mmHg to drain only excess liquid without sucking up the corneal epithelium. The light-shielding structure uses a 0.2mm thick black medical-grade polyimide sheet to cover the outer side of the light path of the temporal oblique light-emitting units. The connection and fixing structure 17 is a slot type, adapted to surgical stents. The partition drive and external parameter input interface 12 uses a USB 2.0 interface to receive corneal thickness map parameters.

[0070] Detailed workflow:

[0071] The irradiation head is mounted on the surgical support via a slot. The position is adjusted to ensure the flexible structure conforms to the corneal limbus, confirming no pressure on the corneal flap. Intermittent fluid infusion is initiated, with riboflavin solution replenished every 20 seconds, maintaining a fluid film thickness of 15-40 μm. Excess fluid is simultaneously drained through the negative pressure interface. External equipment parameters are set according to the corneal thickness map: 4 mW / cm² irradiation for 6 minutes (cumulative 14.4 J / cm²) in the oblique light-emitting unit of the temporal lateral expansion zone, and 3 mW / cm² irradiation for 5 minutes (cumulative 9 J / cm²) in the vertical light-emitting unit of the remaining areas. The treatment time is 8 minutes, with no fluid accumulation throughout. The cornea is rinsed after irradiation.

[0072] Efficacy verification: The cross-linking in the expansion area was uniform, the endothelial UVA dose in the corneal flap area was 0.25 J / cm², there was no additional damage, and the posterior surface height of the expansion area decreased by 12 μm 3 months after the operation, and the condition was stable.

[0073] Example 3: Femtosecond LASIK combined with cross-linking therapy

[0074] Applicable scenarios: Femtosecond LASIK surgery with a remaining stromal bed thickness of 420μm, requiring low-energy reinforcement of the entire area, and suitable for surgical robotic arm positioning.

[0075] In this implementation, the specific parameters of each functional module are as follows:

[0076] The support structure is in very close contact and is not subject to stress. Support structure 2 is made of medical-grade silicone in a dome shape with a radius of curvature of 8.0mm. It is adapted to the curvature of the cornea and supports the outer side of the corneal limbus with a contact pressure of 2mmHg.

[0077] The ultraviolet light transmission window 3 is a planar structure made of cyclic olefin copolymer (COC), with a diameter of 7 mm and a nano anti-fog coating on the surface. The light transmittance decreases by <2% under saturated humidity, and the transmittance of 365nm UVA is ≥95%.

[0078] The microporous fluid replenishment structure has 12 microporous outlets with a pore size of 80 μm, positioned close to the corneal surface. The replenishment flow rate is 0.3 mL / min, and the replenishment fluid is balanced salt solution (BSS). The flow rate deviation of each outlet is <5%.

[0079] There are 16 UVA light-emitting units 7 arranged in a ring. All of them emit light vertically (0° angle), with a wavelength of 365±5nm and an optical power density of 1.5mW / cm². Each unit corresponds to an independent constant current drive circuit.

[0080] The drainage structure uses a miniature negative pressure interface with a negative pressure value set to -5 mmHg, which only drains excess liquid and will not suck up the corneal epithelium; there is no light-shielding structure (all are vertical light-emitting units).

[0081] The connecting and fixing structure 17 adopts a magnetic attraction type, which is compatible with the end of the ophthalmic surgical robotic arm. The magnetic force is 0.6N and the positioning accuracy is <0.1mm. The partition drive and external parameter input interface 12 adopts a fiber optic interface, which can receive the positioning parameters of the robotic arm.

[0082] Detailed workflow:

[0083] The irradiation head is mounted on the end of the robotic arm via a magnetic interface. The robotic arm moves to the cornea according to a preset path and presses down 0.5 mm to make the flexible structure conform to the corneal limbus, with a positioning accuracy of <0.1 mm. BSS solution is continuously output, and the liquid film thickness is maintained at 10-30 μm. Excess liquid is discharged through the negative pressure interface.

[0084] The entire cornea is irradiated with 1.5mW / cm² light for 3 minutes using a vertical light output unit, accumulating 2.7J / cm² energy. The robotic arm then finely adjusts its position along a preset path to cover the entire cornea. The treatment lasts for 5 minutes. After treatment, the robotic arm is removed, and the cornea is rinsed.

[0085] Results verification: Positioning accuracy <0.3mm, stable corneal wetness, endothelial UVA dose 0.1J / cm², no safety risks, and stable postoperative refractive status.

[0086] Example 4: Strengthening treatment for corneal ulcers

[0087] Applicable scenario: Corneal ulcer located in the temporal B zone, requiring cross-linking reinforcement while controlling infection to avoid cross-infection.

[0088] In this implementation, the specific parameters of each functional module are as follows:

[0089] The support structure is extremely close to the cornea and is not subject to stress. Support structure 2 is made of medical-grade silicone in an arc shape (3 segments of 120° arc), avoiding the ulcer area and supporting the periphery of the cornea with a contact pressure of 2 mmHg. The ultraviolet light transmission window 3 is a curved structure made of quartz glass with a diameter of 7 mm and a radius of curvature of 8.0 mm. The surface is coated with an anti-drip coating and has a transmittance of ≥95% for 365nm UVA.

[0090] The microporous replenishment structure has 12 microporous outlets with a diameter of 80 μm, distributed within a 1 mm radius around the irradiation window. The replenishment flow rate is 0.2 mL / min, and the replenishment liquid is a 0.1% riboflavin solution containing 0.02% levofloxacin. The flow rate deviation of each outlet is <5%.

[0091] There are 25 UVA light-emitting units 7 arranged in a honeycomb pattern. Among them, 8 units in the ulcer area emit light at a low incident angle (20°), and the remaining 17 units emit light vertically (0°). The wavelength is 365±5nm, and the light power density is 1mW / cm² in the ulcer area and 3mW / cm² in the remaining areas. Each unit corresponds to an independent constant current drive circuit.

[0092] The drainage structure uses an annular drainage trough with a width of 0.8 mm and a depth of 0.5 mm, located at the bottom of the inner side of the flexible structure, and excess liquid is discharged into the waste liquid collection bag;

[0093] The light-shielding structure uses a 0.2mm thick black medical-grade polyimide sheet to cover the outside of the light-emitting path of the low incident angle light-emitting unit in the ulcer area; the connecting and fixing structure 17 uses a disposable sterile interface (medical-grade PE material), which is disposable after use to avoid cross-infection;

[0094] The partition driver and external parameter input interface 12 adopts a control connection port, which can receive real-time feedback parameters from intraoperative OCT.

[0095] Detailed workflow: The irradiation head is installed on the external cross-linking device via a disposable sterile interface, conforming to the periphery of the cornea, avoiding the ulcer area, and ensuring no pressure. A riboflavin solution containing antibiotics is continuously output, maintaining a liquid film thickness of 10-30 μm. Excess fluid is drained through the drainage channel. Intraoperative OCT monitors corneal thickness in real time. The ulcer area is irradiated for 10 minutes with 1mW / cm² light output from the low incident angle unit (cumulative 6J / cm²), while other areas are irradiated for 5 minutes with 3mW / cm² light output from the vertical light source (cumulative 9J / cm²). Parameters are dynamically adjusted. The treatment time is 12 minutes. After treatment, the irradiation head is discarded, and the cornea is rinsed.

[0096] Efficacy verification: No ulceration was compressed, anti-infection and cross-linking were achieved simultaneously, there was no cross-infection, the ulcer area healed well, and the endothelial UVA dose was 0.2 J / cm², which was safe and controllable.

[0097] Those skilled in the art can make simple modifications to the above embodiments, all of which fall within the protection scope of the present invention: the flexible contact structure 2 can adopt a segmented arc structure to adapt to irregular corneal morphology; the UVA light-emitting unit 7 can adopt an external UVA light source + light guide structure to transmit to the light-emitting end of the irradiation head, and the light guide end face is ground into an angle to achieve non-vertical light emission; the partitioned drive interface 12 can adopt a wireless transmission method to avoid interference with surgery by the connection; the microporous fluid replenishment structure can simultaneously output riboflavin and antibiotics, which is suitable for the treatment of infectious corneal diseases.

[0098] It should be understood that the above description of the embodiments of the present invention is only to make the technical solutions of the present invention clearer and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A contact-type multi-angle corneal ultraviolet cross-linking irradiation head for fluid replenishment, characterized in that, include: The support structure is in very close contact with the non-stressed support structure, which fixes the entire irradiation head in the peripheral area of ​​the cornea, and the irradiation lamp head is in contact with the corneal area to maintain the relative position stability between the irradiation head and the cornea. An ultraviolet light transmission window is set in the center of the irradiation head corresponding to the treatment area, allowing UVA light to pass through and for observation of the corneal surface; A microporous fluid replenishment structure is disposed inside the irradiation head to deliver replenishment fluid to the corneal surface to maintain corneal moisture; Multiple UVA light-emitting units are integrated within the irradiation head and located on the side of the ultraviolet light-transmitting window away from the cornea. Each UVA light-emitting unit corresponds to an independent driving circuit. At least some of the UVA light-emitting units emit light in a direction that is not perpendicular to the local surface of the cornea. The partition drive and external parameter input interface are connected to the drive circuit of the multiple UVA light-emitting units, and are used to receive external control parameters and control the working status of each light-emitting unit.

2. The irradiation head according to claim 1, characterized in that, The support structure is in very close contact with the stress-free support structure and is arranged around the outer periphery of the ultraviolet light transmission window.

3. The irradiation head according to claim 1, characterized in that, The support structure is made of medical-grade silicone, transparent polymer material, or other biocompatible materials suitable for short-term contact with the ocular surface. It is in the form of a ring, arc, shallow cup, dome, or curved surface structure that matches the curvature of the cornea. It supports the periphery of the cornea or the outer region of the limbus, avoiding compression of the central corneal lesion area.

4. The irradiation head according to claim 1, characterized in that, The ultraviolet light transmission window is made of transparent medical or optical materials that are capable of transmitting UVA, and its surface is provided with one or more of the following coatings: hydrophilic, anti-fogging, anti-droplet adhesion, or anti-riboflavin residue; the window is a planar structure or a curved structure adapted to the curvature of the cornea.

5. The irradiation head according to claim 1, characterized in that, The microporous fluid replenishment structure includes a fluid replenishment inlet, an annular fluid replenishment chamber, a micro-fluid replenishment channel, and multiple microporous fluid outlets connected in sequence. The microporous fluid outlets are distributed around the ultraviolet light transmission window, in close contact with the unstressed support structure, or in areas close to the corneal surface. The fluid replenishment liquid includes balanced salt solution, riboflavin solution, or other liquids suitable for the corneal collagen cross-linking process. The fluid replenishment method is continuous micro-fluid replenishment or intermittent fluid replenishment.

6. The irradiation head according to claim 1, characterized in that, The UVA light-emitting unit includes one or more of the following: a miniature UVA LED, an optical fiber light-emitting port, a microlens light-emitting port, or a light-emitting end of the irradiation head transmitted from an external UVA light source through a light guide structure. Multiple UVA light-emitting units are arranged in an array, ring, sector, honeycomb, or partitioned manner.

7. The irradiation head according to claim 1, characterized in that, The non-perpendicular light emission direction is selected from any one or more of the following: a direction oblique to the local surface of the cornea, a direction entering the corneal tissue at a low incident angle, a direction nearly tangential along the local curved surface of the cornea, or a specific direction adjusted by a microlens, microprism, reflective surface, or fiber end face.

8. The irradiation head according to claim 1, characterized in that, It also includes a drainage or reflux structure, which is located inside the irradiation head to drain excess replenishment fluid and maintain a stable, thin, and continuous liquid film on the corneal surface. The drainage or reflux structure includes a drainage trough, a reflux channel, or a micro negative pressure interface.

9. The irradiation head according to claim 1, characterized in that, It also includes a light-shielding structure, which is disposed outside the light-emitting path of the non-perpendicular UVA light-emitting unit to block the non-perpendicular light from scattering outward and prevent it from shining into the eyes of medical personnel.

10. The irradiation head according to claim 1, characterized in that, It also includes a connection and fixing structure, which is disposed on the outer periphery of the irradiation head and avoids the optical path area of ​​the ultraviolet light transmission window, and is used to be detachably connected to the eyelid opener, surgical bracket, robotic arm end, external light source module or corneal cross-linking device body; The connection method is selected from one or more of the following: snap-fit ​​connection, slot connection, threaded connection, magnetic connection, flexible connection, or disposable sterile interface connection.

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