Biological response type conjunctival sac inner protector for orbit radiotherapy

Abstract

The invention belongs to the field of orbit radiotherapy protection, and provides a biological response type conjunctival sac inner protector for orbit radiotherapy, which comprises a lens body, a central light-transmitting area is arranged in the middle of the lens body, a temporal upper shielding area is arranged on one side of the central light-transmitting area, a wearing arc area is arranged on the outer side of the central light-transmitting area, and the wearing arc area is arranged on the outer side of the central light-transmitting area. A side arc area is arranged on the outer side of the wearing arc area, a lower fornix medicine carrying area is arranged on the lower side of the central light-transmitting area, the vertical curvature radius of the lens body is 7.5 mm, the horizontal curvature radius of the lens body is 8.2 mm, and the curvature radius of the side arc area is larger than that of the wearing arc area; through the arrangement of the lens body with the central light-transmitting area, the upper temporal shielding area and the lower fornix drug-loading area, the damage of radiotherapy radiation to the sensitive area of the conjunctival sac can be accurately shielded by combining the directional shielding function of the 120-degree sector section of the upper temporal shielding area, and meanwhile, the drug-loading area integrated with the sodium alginate microspheres is utilized to realize continuous slow release of the drug, so that the curative effect of the drug-loading area is improved. And local tissue protection is enhanced.

Description

Technical Field

[0001] The present invention belongs to the field of orbital radiotherapy protection, and specifically relates to a bio-responsive intra-conjunctival sac protector for orbital radiotherapy. Background Art

[0002] Orbital radiotherapy is one of the important means for treating eye tumors. However, during radiotherapy, the radiation not only acts on the tumor tissue but also causes damage to the surrounding normal tissues, especially the sensitive tissues within the conjunctival sac. As an important part of the eye, the mucosa and glands inside the conjunctival sac are extremely sensitive to radiation and are prone to radiation damage, leading to complications such as dry eye, conjunctivitis, cataract, and retinopathy of the optic nerve, seriously affecting the quality of life of patients.

[0003] Currently, the existing radiotherapy protection technologies mainly focus on external shielding and dose control. Although they reduce the direct harm of radiation to the eyes to a certain extent, they cannot effectively protect the sensitive tissues within the conjunctival sac. Most of the existing protection devices are externally worn shielding equipment, which cannot directly act on the inside of the conjunctival sac and lack the ability to dynamically respond to radiation. They cannot be adjusted in real time according to the change of radiation intensity during radiotherapy, resulting in limited protection effect and great inconvenience.

[0004] Therefore, those skilled in the art have proposed a bio-responsive intra-conjunctival sac protector for orbital radiotherapy to solve the problems raised in the background art. Summary of the Invention

[0005] To solve the above technical problems, the present invention provides a bio-responsive intra-conjunctival sac protector for orbital radiotherapy to solve the problem that most of the existing protection devices are externally worn shielding equipment, which cannot directly act on the inside of the conjunctival sac and lack the ability to dynamically respond to radiation. They cannot be adjusted in real time according to the change of radiation intensity during radiotherapy, resulting in limited protection effect.

[0006] A bio-responsive intra-conjunctival sac protector for orbital radiotherapy includes a lens body. A central light-transmitting area is provided in the middle of the lens body. A superotemporal shielding area is provided on one side of the central light-transmitting area. A wearing arc area is provided outside the central light-transmitting area. A side arc area is provided outside the wearing arc area. An inferior fornix drug-loading area is provided below the central light-transmitting area;

[0007] The vertical radius of curvature of the lens body is 7.5 mm, and the horizontal radius of curvature is 8.2 mm;

[0008] The radius of curvature of the side arc area is greater than that of the wearing arc area.

[0009] Preferably, the cross-sectional area of the superotemporal shielding area is in a fan shape and its angle is 120°.

[0010] Preferably, a number of uniformly distributed integrated sodium alginate microspheres are provided in the lower fornix drug-loading area.

[0011] Preferably, the integrated sodium alginate microspheres have a diameter of 10-20 μm.

[0012] Preferably, the lens body is sequentially provided with a lubricating layer, a honeycomb layer and a temperature-sensitive adsorption layer from top to bottom.

[0013] Preferably, the lubricating layer is a ph lubricating layer, and its material is a chitosan-acrylic acid copolymer.

[0014] Preferably, the inside of the honeycomb layer is a honeycomb-like microstructure with a pore diameter of 50 μm.

[0015] Preferably, the lens body is provided with a gradually tapered edge, and the thickness of the wearing arc area gradually decreases from the direction close to the central light-transmitting area to the direction away from the central light-transmitting area.

[0016] Through the above technical solutions,

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] 1. Through the lens body of the central light-transmitting area, the superotemporal shielding area and the lower fornix drug-loading area provided by the present invention, combined with the directional shielding function of the 120° sector cross-section of the superotemporal shielding area, it can accurately block the damage of radiotherapy radiation to the sensitive area of the conjunctival sac, and at the same time utilize the drug-loading area of the integrated sodium alginate microspheres to achieve the sustained release of drugs and enhance the local tissue protection.

[0019] 2. Through the multi-layer structure design of the lubricating layer, the honeycomb layer and the temperature-sensitive adsorption layer provided, the wearing comfort and air permeability are significantly improved, and its temperature-sensitive adsorption characteristics can dynamically respond to the temperature change of the eye to optimize the fitting degree; the gradually tapered edge and the differential design of the curvature radius further fit the physiological structure of the eye and reduce the foreign body sensation, so as to achieve the efficient protection and treatment coordination of the sensitive tissues in the conjunctival sac while ensuring the radiotherapy accuracy, and solve the problems of the existing external protection device that cannot dynamically respond and has insufficient action targeting. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a top view of the present invention;

[0021] Figure 2 is a front view of the present invention;

[0022] Figure 3 is a schematic structural diagram of the lubricating layer of the lens interface in the present invention.

[0023] In the figure:

[0024] 1. Lens body; 2. Central light-transmitting area; 3. Superotemporal shielding area; 4. Wearing arc area; 5. Edge arc area; 6. Inferior fornix drug-loading area; 7. Lubricating layer; 8. Honeycomb layer; 9. Thermosensitive adsorption layer. Detailed implementation manners

[0025] The following further describes the implementation manners of the present invention in detail with reference to the drawings and embodiments. The following embodiments are used to illustrate the present invention, but cannot be used to limit the scope of the present invention.

[0026] Embodiment 1: As shown in the attached Figure 1 to the attached Figure 3 figures: The present invention provides a bio-responsive intraconjunctival protector for orbital radiotherapy, including a lens body 1. A central light-transmitting area 2 is provided in the middle of the lens body 1, which is made of a high light-transmitting PDMS material (light transmittance ≥ 82%), and an anti-reflection nano-coating is plated on the surface to ensure the clarity of real-time image navigation during radiotherapy. A superotemporal shielding area 3 is provided on the superotemporal side of the central light-transmitting area 2. Its cross-section is a 120° sector, covering the lens projection area, and is filled with a tungsten / bismuth nano-composite material (particle size 50 - 80 nm). The thickness gradient is designed to be 0.6 mm on the nasal side to 0.3 mm on the temporal side, achieving a radiation shielding performance equivalent to 0.35 mm Pb, and the lens dose attenuation rate for 6 MV high-energy photon beams ≥ 82%;

[0027] Furthermore, the lens body is provided with a gradually thinning edge. The thickness of the wearing arc area gradually decreases from the direction close to the central light-transmitting area 2 to the direction away from the central light-transmitting area 2.

[0028] The vertical curvature radius of the lens body 1 is 7.5 mm - 8.5 mm, which is adapted to different models. Specifically, 1. Adult models (3 specifications)

[0029] Small size: Curvature radius 7.0 - 7.5 mm, depth 10 - 12 mm (adapted to eyeballs with a sagittal diameter of 24 - 25 mm)

[0030] Medium size: Curvature radius 7.5 - 8.0 mm, depth 12 - 13 mm (adapted to eyeballs with a sagittal diameter of 25 - 26 mm)

[0031] Large size: Curvature radius 8.0 - 8.5 mm, depth 13 - 14 mm (adapted to eyeballs with a sagittal diameter of 26 - 27 mm); 2. Child models (2 specifications)

[0032] Infant type: Curvature radius 5.5 - 6.0 mm, depth 7 - 8 mm (adapted to children aged 3 - 6 years)

[0033] Adolescent type: Curvature radius 6.0 - 7.0 mm, depth 8 - 10 mm (adapted to adolescents aged 7 - 14 years)

[0034] The horizontal curvature radius is 8.2 mm, which is adapted to the depth of the conjunctival sac (10 - 14 mm). The edge adopts a gradually thinned design (the nasal side thickness is 0.6 mm to the temporal side thickness of 0.3 mm), reducing the pressure on the eyelids. The curvature radius of the edge arc area 5 is greater than that of the wearing arc area 4, ensuring a fit with the fornix of the conjunctival sac. Combined with a magnetically controlled positioning system (a Φ0.3 mm NdFeB micro-magnetic ring is embedded in the edge, with a positioning accuracy of ±0.5 mm), the device displacement rate is ≤5%;

[0035] Preferably, the thermosensitive material uses a poly-N-isopropylacrylamide (PNIPAM) edge layer. When the temperature ≥ 34°C (ocular surface temperature), the shrinkage rate is 15% - 20%, causing the curvature to adaptively increase by 0.2 - 0.5 mm. The magnetically controlled fine-tuning module embeds a NdFeB magnetic ring (diameter 0.3 mm) at the edge of the device, and applies an adsorption force of 0.1 - 0.5 N through an external navigation magnetic sticker to achieve an accuracy adjustment of the curvature radius of ±0.3 mm;

[0036] The adjustment principle of the thermosensitive material of the radiation protection device. The thermosensitive material mainly undertakes the functions of dynamic fitting adjustment and biological response in the radiation protection device. Its action principle combines thermodynamic phase change and material property response. The specific mechanism is as follows: I. Temperature-responsive adsorption mechanism

[0037] 1. Phase change-triggered fixation

[0038] Poly-N-isopropylacrylamide (PNIPAM) is used as the adsorption layer material, and its lower critical solution temperature (LCST) is set at 34°C (close to the temperature of the conjunctival sac).

[0039] Low temperature (<34°C): The material is in a hydrophilic swollen state, with a soft surface and no adhesiveness, facilitating non-invasive operation during device implantation.

[0040] High temperature (≥34°C): The material undergoes hydrophobic shrinkage, generating an adsorption force of about 0.5 - 1.2 kPa, causing the device to closely fit the fornix of the conjunctival sac and preventing displacement during radiotherapy.

[0041] 2. Mechanical adaptation optimization

[0042] By regulating the cross-linking density of PNIPAM (10 - 20 wt%), the elastic modulus of the material is matched with the conjunctival tissue (0.1 - 1 MPa), avoiding mechanical damage caused by excessive hardness.

[0043] II. Temperature-dependent lubrication regulation

[0044] 1. Chitosan-acrylic acid copolymer lubricating layer When the conjunctival sac becomes inflamed due to radiotherapy, the local temperature rises (>37°C), causing the carboxylic acid groups of the material to dissociate and release pre-loaded hyaluronic acid nanoparticles (particle size 50-100 nm), reducing the coefficient of friction from 0.8 to 0.24. After the temperature returns to normal, the material realizes the slow release of the lubricant through hydrogen bond recombination to avoid excessive consumption.

[0045] 2. Thermally induced oxygen permeability regulation. In the range of 33-37°C, the oxygen permeability (Dk value) of the nanocellulose / PDMS composite film in the shielding layer increases from 80 to 180, alleviating the risk of corneal hypoxia. Specifically, the lens manufacturing process uses DLP photocuring technology with a layer thickness of 25 μm and a surface forming error ≤ ±0.05 mm.

[0046] The curvature radius of the edge arc area 5 is greater than that of the wearing arc area 4.

[0047] As can be seen from the above, through the set lens body 1, the central light-transmitting area 2 is provided in the middle, using a high-light-transmitting PDMS material (light transmittance ≥ 82%) and coated with an anti-reflection nano-coating to ensure the clarity of image navigation during radiotherapy. The superotemporal shielding area 3 is a 120° sector, filled with tungsten / bismuth nano-composite material (particle size 50-80 nm) inside, and the thickness gradient is designed from 0.6 mm on the nasal side to 0.3 mm on the temporal side, achieving a radiation shielding performance equivalent to 0.35 mm Pb, and the lens dose attenuation rate for 6MV high-energy photon beam ≥ 82%. The edge of the lens body 1 adopts a gradually thinning design, with a vertical curvature radius of 7.5 mm and a horizontal curvature radius of 8.2 mm. Combined with a magnetron positioning system (a Φ0.3 mm NdFeB micro-magnet ring is embedded at the edge, with a positioning accuracy of ±0.5 mm), it ensures that the device displacement rate ≤ 5%, reduces the pressure on the eyelids and improves the wearing stability.

[0048] Example 2: As shown in the attached Figure 1 to the attached Figure 3 figures: This example is basically the same as the previous example, except that the cross-sectional area of the superotemporal shielding area 3 is set as a sector, and its angle is 120°. A number of uniformly distributed integrated sodium alginate microspheres are arranged in the lower fornix drug-loading area 6. The diameter of the integrated sodium alginate microspheres is 10-20 μm, loaded with dexamethasone (0.05 wt%) and cyclosporine A (0.1 wt%), crosslinked and cured by CaCl2, and the cumulative drug release rate in 72 hours ≥ 90%, effectively preventing radioactive conjunctivitis.

[0049] As can be seen from the above, in the functional design of the lower fornix drug-loading area 6, integrated sodium alginate microspheres (with a diameter of 10 - 20 μm) are evenly distributed, loaded with dexamethasone (0.05 wt%) and cyclosporine A (0.1 wt%). Through cross-linking and curing with CaCl2, a cumulative drug release rate of ≥90% is achieved within 72 hours, effectively preventing radioactive conjunctivitis. The 120° sector design of the superotemporal shielding area 3 precisely covers the lens projection area, combined with the high light transmittance characteristics of the central light-transmitting area 2, ensuring the compatibility of the protection of sensitive tissues and real-time image navigation during radiotherapy.

[0050] Example 3: As shown in the appendix Figure 3 : On the basis of Example 1, the lens body 1 adopts a layered composite structure: the surface layer is a pH-responsive lubricating layer 7, made of a chitosan-acrylic acid copolymer, and the friction coefficient dynamically drops to 0.02 - 0.05 (simulating the tear fluid environment). The middle layer is a honeycomb layer 8 formed by laser engraving with a honeycomb microstructure with a pore diameter of 50 μm and a porosity of 65% (oxygen permeability Dk = 180), avoiding corneal hypoxia. The bottom layer is a temperature-sensitive adsorption layer 9, made of PNIPAM material, generating a controllable adsorption force of 0.5 - 1.2 kPa at 34°C, dynamically adapting to the blinking movement.

[0051] As can be seen from the above, the multi-layer functional structure of the lens body 1 has a surface layer of a pH-responsive lubricating layer 7, made of a chitosan-acrylic acid copolymer, and the friction coefficient dynamically drops to 0.02 - 0.05 (simulating the tear fluid environment), improving wearing comfort. The middle layer is a honeycomb layer 8, formed by laser engraving with a honeycomb microstructure with a pore diameter of 50 μm and a porosity of 65% (oxygen permeability Dk = 180), avoiding corneal hypoxia. The bottom layer is a temperature-sensitive adsorption layer 9, made of PNIPAM material, generating a controllable adsorption force of 0.5 - 1.2 kPa at 34°C, dynamically adapting to the blinking movement, ensuring the stability of the device during eye movement. This multi-layer structure design significantly improves the biocompatibility and functionality of the protector.

[0052] The embodiments of the present invention are given for the purpose of illustration and description. Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present invention.

[0053] In the description of the present invention, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. The meaning of "plurality" is two or more, unless otherwise specifically defined.

[0054] In the present invention, unless otherwise clearly defined or limited, terms such as "installed", "connected", "joined", "fixed", etc. shall be construed in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the internal communication of two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] In the present invention, unless otherwise clearly defined or limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0056] In the description of this specification, the description with reference to terms such as "one embodiment", "some embodiments", "example", "specific example" or "some examples", etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, without conflict, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0057] In the drawings of the disclosed embodiments of the present invention, only the structures related to the disclosed embodiments are involved, and other structures can refer to the general design. Without conflict, the same embodiment and different embodiments of the present invention can be combined with each other.

[0058] Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A bio-responsive conjunctival sac protector for orbital radiotherapy, characterized in that: The lens comprises a lens body (1), wherein a central light-transmitting area (2) is arranged in the middle of the lens body (1), a superior temporal shielding area (3) is arranged on one side of the central light-transmitting area (2), a wearing arc area (4) is arranged on the outer side of the central light-transmitting area (2), a side arc area (5) is arranged on the outer side of the wearing arc area (4), and a lower fornix drug-carrying area (6) is arranged on the lower side of the central light-transmitting area (2); The vertical curvature radius of the lens body (1) is 7.5 mm, and the horizontal curvature radius is 8.2 mm; The curvature radius of the edge arc area (5) is greater than the curvature radius of the wearing arc area (4).

2. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 1, characterized in that: The cross-sectional area of ​​the upper temporal shielding area (3) is arranged in a fan-shaped manner, and its angle is 120°.

3. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 1, characterized in that: A plurality of evenly distributed integrated sodium alginate microspheres are arranged in the lower fornix drug loading area (6).

4. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 3, characterized in that: The diameter of the integrated sodium alginate microspheres is 10-20 μm.

5. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 1, characterized in that: The lens body (1) is provided with a lubricating layer (7), a honeycomb layer (8) and a temperature-sensitive adsorption layer (9) in sequence from top to bottom.

6. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 5, characterized in that: The lubricating layer (7) is a pH lubricating layer (7), and its material is chitosan-acrylic acid copolymer.

7. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 5, characterized in that: The honeycomb layer (8) has a honeycomb microstructure with a pore size of 50 μm.

8. A bio-responsive conjunctival sac protector for orbital radiotherapy as claimed in claim 1, characterized in that: The lens body (1) is configured to be gradually thinned at the edge, and the thickness of the wearing arc area (4) gradually decreases from close to the central light-transmitting area (2) to away from the central light-transmitting area (2).

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