Personalized corneal contact lens microneedle device for treating corneal dilation diseases

Abstract

The utility model provides a personalized corneal contact lens microneedle device for treating corneal dilation diseases, which comprises a fixing device and a drug delivery device, the drug delivery device comprises a drug delivery main body and a drug delivery microneedle arranged on the drug delivery main body; the fixing device surrounds the periphery of the drug delivery main body and is concentric with the drug delivery main body and embedded with the drug delivery main body; wherein the fixing device fixes the whole corneal contact lens microneedle device on the surface of a cornea through the fixing microneedle, a biomechanical effect is generated around the cornea to control the corneal curvature progress, and meanwhile, the medicine delivery microneedle is fixed in the center of the cornea; the drug delivery microneedle is used for penetrating through the cornea epithelium to reach the cornea stroma layer, so that the drug on the drug delivery main body permeates into the cornea stroma layer, and finally, the thickness and hardness of the cornea stroma layer are increased in combination with ultraviolet irradiation, and the disease progress is controlled. The treatment mode of the device is safe and efficient, and nano-drugs are not needed.

Description

Technical Field

[0001] This invention belongs to the medical field, and in particular relates to a personalized corneal contact lens microneedle device for the treatment of corneal ectasia. Background Technology

[0002] Corneal ectasia refers to a group of ophthalmic diseases that alter the morphology and function of the cornea, typically manifesting as anterior convexity or irregular expansion of the cornea. Corneal ectasia includes the following types: ① Keratoconus: This eye disease is characterized by central or paracentral corneal expansion and thinning, resulting in a cone-shaped protrusion forward. It often leads to high irregular astigmatism, severely affecting visual quality; late-stage patients may experience significant vision loss or even blindness. ② Post-refractive corneal topography: This is a complication associated with refractive surgery, characterized by abnormal expansion and irregular shape of the cornea. ③ Corneal degeneration: This is a relatively rare hereditary disease where the cornea exhibits uniform expansion and thinning, often accompanied by eyeball deformities. ④ Flat cornea: This is a relatively rare corneal morphological abnormality where the cornea has a flatter curvature, potentially leading to mild myopia or visual problems. It is characterized by a lack of normal curvature on the anterior surface of the cornea and usually does not involve significant visual impairment. ⑤ Posterior corneal ectasia is an expansion of the inner layer of the cornea, mainly manifested as a protrusion on the posterior surface of the cornea. It is usually inconspicuous, and early symptoms are not obvious. ⑥ Other causes of corneal ectasia.

[0003] Treatment methods for these corneal ectasias vary depending on the severity of the condition and typically include wearing eyeglasses, rigid gas permeable contact lenses, corneal collagen cross-linking therapy, and corneal transplantation. Early and effective intervention can slow disease progression and reduce the burden of the disease. However, current clinical practice shows that non-surgical interventions are insufficient to delay or stop the progression of corneal ectasia. For patients with rapidly progressing disease, corneal collagen cross-linking or even corneal transplantation is still necessary. In corneal ectasias or early-stage keratoconus (thinnest part of the cornea greater than 400 μm), corneal collagen cross-linking can slow disease progression to some extent. Due to the barrier effect of the corneal epithelium on large molecules such as riboflavin, the corneal epithelium needs to be scraped during the procedure to allow riboflavin to effectively penetrate into the corneal stroma. Combined with ultraviolet light irradiation, the corneal stromal cells react with riboflavin to produce a collagen cross-linking reaction, improving the mechanical strength of the corneal tissue and resisting corneal ectasia. When the disease progresses further or the cornea thins to less than 400 μm, corneal transplantation becomes the primary treatment.

[0004] The disadvantages of current technology are as follows: Corneal collagen cross-linking surgery: (1) The corneal epithelium must be scraped off in order for riboflavin to reach the corneal stroma layer where it needs to act. The corneal epithelium is rich in nerves, and scraping will cause irritation and pain, and there is a risk of corneal infection or even ulceration. Especially for patients with diabetes or long-term use of hormone drugs, corneal epithelial defects are not easy to recover, and may even be chronic; (2) The scope of corneal collagen cross-linking depends on the doctor's experience, and it is impossible to accurately and objectively target the thinned corneal area for collagen cross-linking. Corneal transplantation surgery: Donor corneal resources are scarce, and there is a risk of immune rejection and infection after corneal transplantation.

[0005] Regarding research progress both domestically and internationally, some scholars have proposed contact lens-assisted corneal cross-linking. This technique involves placing a contact lens soaked in riboflavin onto the patient's corneal surface to promote riboflavin penetration into the corneal stroma. However, the hydrophilic contact lenses used in this technique have low drug loading capacity, making it difficult to meet the drug concentration required for effective cross-linking; moreover, it still requires scraping the corneal epithelium, failing to overcome the challenges of existing technologies. In recent years, numerous studies have actively explored non-invasive methods for corneal cross-linking using riboflavin combined with ultraviolet irradiation, such as riboflavin composite nanomaterials for transepithelial drug delivery, which can effectively deliver riboflavin to the corneal stroma without removing the corneal epithelium. This design, by optimizing the drug delivery system, avoids corneal epithelial damage while maintaining an effective concentration of riboflavin in the stroma. However, the safety of nanomedicines after entering the eye still needs further investigation; their distribution, metabolism, and absorption pathways within the eye are not yet clear, necessitating a novel, safe, and efficient treatment method. Utility Model Content

[0006] To address the shortcomings of the existing technology, this invention provides a personalized corneal contact lens microneedle device for the treatment of corneal ectasia. This corneal contact lens microneedle device avoids corneal epithelial damage, delivers a sufficient concentration of drug to the corneal stroma, and does not require the use of nanomedicine, resulting in a safe and efficient treatment effect.

[0007] The purpose of this invention is to provide a personalized corneal contact lens microneedle device for the treatment of corneal ectasia, comprising:

[0008] A drug delivery device includes a drug delivery body and a drug delivery microneedle disposed on the drug delivery body;

[0009] A fixing device is arranged around the outer periphery of the drug delivery body and concentrically with and fitted into the drug delivery body;

[0010] The fixation device is used to fix the drug delivery body to the corneal thinning area, and the drug delivery microneedle is used to penetrate the corneal epithelium to reach the corneal stroma, so that the drug on the drug delivery body can penetrate into the corneal stroma. Combined with ultraviolet light irradiation, it can achieve the therapeutic effect of increasing the thickness and hardness of the cornea in the thinning area.

[0011] In some embodiments of this utility model, the fixing device includes a peripheral area for adhering to the corneal surface to fix the personalized corneal contact lens microneedle device to the corneal surface.

[0012] In some embodiments of this utility model, the fixing device further includes fixing microneedles disposed on the peripheral area. The fixing microneedles are used to penetrate the corneal epithelium and the superficial stroma to fix the corneal contact lens device, so that the fixing area is closely attached to the corneal surface around the thinned corneal area. The fixing microneedles and the fixing area control the corneal curvature through biomechanical action in the periphery of the cornea.

[0013] In some embodiments of this utility model, the shape of the fixing microneedle includes, but is not limited to, "pine tree shape" or "arrow shape".

[0014] In some embodiments of the present invention, the peripheral region includes a first posterior surface facing the corneal surface and an anterior surface facing away from the corneal surface, wherein the first posterior surface is a plane and the anterior surface is an arc surface.

[0015] In some embodiments of this utility model, the peripheral area includes a connecting area, a fixing area, and an edge area arranged sequentially from the direction close to the drug delivery body to the direction far from the drug delivery body. The connecting area is connected to the drug delivery body, and the fixing microneedle is disposed in the fixing area.

[0016] In some embodiments of this invention, the fixation area further includes a second posterior surface facing the corneal surface, the fixation microneedle is disposed on the second posterior surface, and the angle between the tangent of the contact point of the second posterior surface and the needle body of the fixation microneedle is ≤90°. o .

[0017] In some embodiments of this utility model, the drug delivery body is provided with a first micropore, and the drug delivery microneedle is provided with a second micropore, a liquid guiding channel and a third micropore connected in sequence from the needle tail to the needle tip. The needle tail of the drug delivery microneedle is connected to the drug delivery body so that the second micropore is connected to the first micropore. When the needle tip of the drug delivery body penetrates to the corneal stroma, the third micropore is used to permeate the drug into the corneal stroma.

[0018] In some embodiments of this utility model, the drug delivery body is provided with a first connecting part, and the fixing device is provided with a second connecting part. The second connecting part is connected to the first connecting part to connect the fixing device to the drug delivery device.

[0019] In some embodiments of this utility model, the material of the fixing device includes, but is not limited to, at least one of fluorosilyl polymer, polymethyl methacrylate, silicone hydrogel, and polyurethane.

[0020] In some embodiments of the present invention, the material of the drug delivery device includes, but is not limited to, at least one of polylactic acid, polyhydroxyalkanoate, and polylactic acid-glycolic acid copolymer.

[0021] Another objective of this invention is to provide a method for preparing the personalized corneal contact lens microneedle device for the treatment of corneal ectasia, comprising the following steps:

[0022] S1. Obtain each person's unique corneal morphology parameters, and based on these parameters, create a personalized drug delivery device mold using 3D printing, targeting the area of ​​corneal thinning.

[0023] S2. Melt the material used to prepare the drug delivery device, heat it to 150℃-160℃, pour it into the drug delivery device mold, remove air bubbles, cool and solidify, and obtain the drug delivery device after demolding.

[0024] S3. Use 3D printing technology to print the fixing device, then photocur and clean it to obtain the fixing device;

[0025] S4. The drug delivery device and the fixation device are tightly connected and cleaned and disinfected to obtain a corneal contact lens microneedle device for the treatment of corneal ectasia.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The fixation device of this utility model fixes the entire corneal contact lens microneedle device to the corneal surface by fixing the microneedle; it generates a biomechanical effect in the periphery of the cornea to control the progression of corneal curvature, and at the same time fixes the drug delivery microneedle to the center of the cornea by the interlocking device; the drug delivery microneedle is used to penetrate the corneal epithelium to reach the corneal stroma to allow the drug on the drug delivery body to penetrate into the corneal stroma, and finally, combined with ultraviolet light irradiation, it increases the thickness and hardness of the corneal stroma and controls the progression of the disease.

[0028] (2) The microneedle device for corneal contact lenses of this utility model can combine biomechanical action and drug curing action to control corneal thinning, expansion and curvature progression. Furthermore, the minimally invasive and biodegradable design of the microneedle avoids corneal epithelial damage caused by traditional treatment methods, resulting in more efficient and safer treatment.

[0029] (3) This utility model can combine the biomechanical effect of the fixed microneedle of the fixation device with the drug treatment of the drug delivery device to achieve a 1+1>2 effect.

[0030] (4) This utility model can customize a personalized corneal contact lens microneedle device according to the corneal morphological characteristics of different patients, avoiding the traditional one-size-fits-all approach. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 A schematic diagram of a personalized corneal contact lens microneedle device for the treatment of corneal ectasia.

[0033] Figure 2 This is a magnified schematic diagram of a portion of the microneedle used for drug delivery.

[0034] Figure 3 This is a schematic diagram illustrating two different connection methods for drug delivery devices and fixation devices.

[0035] Figure 4 For the microscopic morphology characterization and penetration ability testing of drug delivery microneedles;

[0036] Figure 5 The dissolution of drug delivery microneedles within 30 minutes after contact with artificial tears;

[0037] Figure 6 To test the penetration capability of drug delivery microneedles in corneal tissue;

[0038] Figure 7 To assess the in vivo biosafety and efficacy of a personalized corneal contact lens microneedle device for the treatment of corneal ectasia.

[0039] 1. Fixation device; 2. Drug delivery device; 3. Edge area; 4. Fixation area; 5. Connection between the fixation device and the drug delivery device; 6. Fixation microneedle; 7. Peripheral area; 8. Drug delivery microneedle; 9. Micropore; 10. Drug delivery body. Detailed Implementation

[0040] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0041] In this invention, the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," "middle," "vertical," "horizontal," "lateral," and "longitudinal" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are primarily for the purpose of better describing this invention and its embodiments, and are not intended to limit the indicated device, element, or component to having a specific orientation, or to be constructed and operated in a specific orientation.

[0042] Furthermore, in addition to indicating direction or positional relationship, some of the aforementioned terms may also have other meanings. For example, the term "above" may also be used in some cases to indicate a certain dependency or connection relationship. Those skilled in the art can understand the specific meaning of these terms in this utility model according to the specific circumstances.

[0043] Furthermore, the terms "installation," "setup," "equipped with," "connection," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral structure; 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, or an internal connection between two devices, components, or parts. Those skilled in the art can understand the specific meaning of these terms in this utility model based on the specific circumstances.

[0044] Furthermore, the terms "first," "second," etc., are primarily used to distinguish different devices, components, or parts (which may be the same or different in specific type and construction), and are not intended to indicate or imply the relative importance or quantity of the indicated devices, components, or parts. Unless otherwise stated, "a plurality of" means two or more.

[0045] The technical solution of this utility model will be further described below with reference to the embodiments and accompanying drawings.

[0046] Please see Figures 1 to 3To achieve the above objectives, the first aspect of this utility model provides a personalized corneal contact lens microneedle device for the treatment of corneal ectasia, comprising: a drug delivery device (2) and a fixation device (1), wherein the drug delivery device (2) includes a drug delivery body (10) and a drug delivery microneedle (8) disposed on the drug delivery body; the fixation device (1) surrounds the outer periphery of the drug delivery body (10) and is concentric with and fitted with the drug delivery body (10);

[0047] The fixation device is used to fix the drug delivery body to the corneal thinning area. The drug delivery microneedles are used to penetrate the corneal epithelium to reach the corneal stroma, so that the drug on the drug delivery body can penetrate into the corneal stroma. Combined with ultraviolet light irradiation, the treatment effect of increasing the thickness and hardness of the cornea in the thinning area is achieved.

[0048] This invention, during cross-linking surgery for the treatment of corneal ectasia, utilizes drug delivery microneedles in the central zone to penetrate the corneal epithelium and reach the corneal stroma. This allows the medication to permeate into the corneal stroma, achieving a therapeutic effect without the need for corneal epithelial scraping. This avoids corneal epithelial damage while delivering a sufficient concentration of medication to the corneal stroma. Finally, combined with ultraviolet light irradiation, the thickness and hardness of the corneal stroma increase, controlling disease progression. This invention eliminates the need for nanomedicine, resulting in a safe and highly effective treatment.

[0049] Furthermore, the fixation device (1) includes a peripheral area (7) for adhering to the corneal surface to fix the personalized corneal contact lens microneedle device to the corneal surface.

[0050] Understandably, the peripheral zone is designed to adhere to the corneal surface. In actual use, it can be made into different shapes (such as round, oval, etc.) according to the shape of the corneal epithelium of different patients to meet different usage needs.

[0051] Furthermore, the fixation device (1) also includes a fixation microneedle (6) disposed on the peripheral area (7). The fixation microneedle (6) is used to penetrate the corneal epithelium and the superficial stroma to fix the corneal contact lens device, so that the fixation area is closely attached to the corneal surface around the thinned corneal area. The fixation microneedle and the fixation area control the corneal curvature through biomechanical action in the periphery of the cornea.

[0052] This invention uses fixed microneedles in the peripheral area to apply force to the corneal surface, preventing further corneal expansion and thinning, reducing corneal curvature to inhibit the progression of corneal thinning, shortening the arc length of the thinned area, and reducing abnormal corneal refractive power. Through the combined action of the drug delivery microneedles of the drug delivery device and the fixation device, a combined therapeutic effect of corneal biomechanical fixation and collagen cross-linking is achieved for corneal ectasia, resulting in a synergistic effect greater than the sum of its parts.

[0053] Furthermore, the shape of the fixed microneedle (6) includes, but is not limited to, "pine tree shape" or "arrow shape".

[0054] Furthermore, the width of the peripheral area (7) is 8-28mm and the center thickness is 0.15-0.2mm.

[0055] The overall coverage area of ​​the peripheral region of this utility model includes the cornea, limbus, and sclera, in order to meet the corneal morphology requirements of various corneal ectasia diseases.

[0056] Furthermore, the peripheral region (7) includes a first posterior surface facing the corneal surface and an anterior surface facing away from the corneal surface, wherein the first posterior surface is planar and the anterior surface is arcuate.

[0057] The first posterior surface of the peripheral area of ​​the personalized corneal contact lens microneedle device for the treatment of corneal ectasia is flat. During the cross-linking surgery for the treatment of corneal ectasia, as the edge area and / or the fixing microneedle are inserted into the corneal epithelium, the first posterior surface changes from a flat surface to an arc surface with a certain curvature, which enhances its fixation effect, conforms to the corneal curvature, and makes it stably fixed to the cornea. It also effectively shortens the arc length of the thinned cornea, prevents the cornea from further protruding and / or thinning, and maintains the stability of the corneal curvature.

[0058] Furthermore, the peripheral area (7) includes a connecting area, a fixing area (4), and an edge area (3) arranged sequentially from the direction close to the drug delivery body to the direction far away from the drug delivery body. The connecting area is connected to the drug delivery body, and the fixing microneedle (6) is disposed in the fixing area (4).

[0059] The edge area of ​​this invention contacts the inner or outer side of the limbus, and is used to fix and position the cornea or sclera, while avoiding damage to the limbus cells by the fixation microneedles.

[0060] Furthermore, the width of the fixed area (4) is 3-4 mm and the thickness is 150-600 μm.

[0061] Furthermore, the fixation area (4) also includes a second posterior surface facing the corneal surface, on which the fixation microneedle (6) is disposed, and the angle between the tangent of the contact point of the second posterior surface and the needle body of the fixation microneedle (6) is ≤90°. o .

[0062] This invention relates to a microneedle fixed on the second posterior surface of the fixation area, the width of which is suitable for patients with thinning of the central or peripheral cornea. For patients with thinning of the central cornea, the microneedle can be fixed 0.2-0.6 mm medial to the limbus; when applicable to patients with thinning of the peripheral cornea, the microneedle can be fixed 1-4 mm lateral to the limbus on the sclera.

[0063] When the angle between the tangent of the contact point on the second rear surface and the needle body of the fixed microneedle is ≤90° o This makes it difficult for the fixed microneedles to shift after they are inserted into the corneal epithelium, thus enhancing the fixation effect and achieving a mechanical action similar to the corneal stromal ring.

[0064] Furthermore, the fixation area (4) also includes a second posterior surface facing the corneal surface, the fixation microneedle (6) is disposed on the second posterior surface, and the angle between the tangent of the contact point of the second posterior surface and the needle body of the fixation microneedle (6) is 5-45°.

[0065] When the angle between the tangent of the contact point on the second posterior surface and the needle body of the fixation microneedle is 5-45°, it makes it more difficult for the fixation microneedle to shift after it is inserted into the corneal epithelium, thus further enhancing its fixation effect.

[0066] Furthermore, the angle between the tangent of the contact point on the second rear surface and the needle body of the fixed microneedle (6) is 15-30°.

[0067] Furthermore, the arc length of the front surface is 7-8.65 mm.

[0068] Furthermore, the width of the edge region (3) is 0.5-1mm.

[0069] Furthermore, the fixed microneedle (6) has a needle tail diameter of 2.5-3.5 mm, a spacing of 0.1 mm, a needle tip spacing of 0.5-0.9 mm, a needle body height of 0.4-0.7 mm, and a needle tip diameter of 0.5-0.7 mm.

[0070] Furthermore, the diameter of the drug delivery body (10) is 4-10 mm and the thickness is 0.15-0.4 mm.

[0071] Please see Figure 1 and Figure 2Furthermore, the drug delivery body (10) is provided with a first micropore, and the drug delivery microneedle (8) is provided with a second micropore, a liquid channel and a third micropore connected in sequence from the needle tail to the needle tip. The needle tail of the drug delivery microneedle (8) is connected to the drug delivery body (10) so that the second micropore is connected to the first micropore. When the needle tip of the drug delivery body (10) penetrates to the corneal stroma layer, the third micropore is used to permeate the drug into the corneal stroma layer.

[0072] It is understood that when the present invention adds additional drug to the surface of the drug delivery body, the drug can penetrate into the corneal stroma through the first micropore, the second micropore, the liquid channel and the third micropore.

[0073] This invention applies a corneal contact lens microneedle device to the treatment of corneal ectasia. A drug (such as riboflavin) is added to the drug delivery microneedle, which is then worn on the patient's cornea. The drug delivery microneedle penetrates the corneal epithelium through a minimally invasive procedure, reaching the corneal stroma. The drug permeates into the corneal stroma through the micropores of the drug delivery microneedle, releasing the initial drug load and thus achieving a therapeutic effect. When the effective drug concentration is insufficient, the drug can be continuously dripped through the hollow micropores in the drug delivery device. The drug enters the drug delivery microneedle from the central micropores and then enters the patient's corneal stroma through the micropores of the drug delivery microneedle, achieving an effective drug concentration and ultimately realizing the safe and efficient transepithelial delivery of riboflavin.

[0074] When the effective concentration of the drug is insufficient, the drug delivery device may begin to degrade as the drug is continuously dripped through the hollow micropores in the drug delivery device. During the degradation process of the drug delivery device, the drug can still be continuously delivered through the hollow structure of the microneedles until the drug reaches an effective concentration.

[0075] Furthermore, the drug delivery body (10) is provided with a first connecting part, and the fixing device (1) is provided with a second connecting part. The second connecting part is connected to the first connecting part so as to connect the fixing device (1) to the drug delivery device (2).

[0076] As can be seen from the above, the fixing device (1) is connected to the drug delivery body (10) through the connection area of ​​the peripheral area (7), and therefore, the second connection part is provided on the connection area of ​​the peripheral area (7).

[0077] Please see Figure 3 Furthermore, the first connecting part is one of a snap-fit ​​tip and a snap-fit ​​groove, and the second connecting part is the other of a snap-fit ​​tip and a snap-fit ​​groove.

[0078] The drug delivery device and the fixation device of this invention are connected by a snap-fit ​​tip and a snap-fit ​​groove. On the one hand, it can maintain a stable connection between the fixation device and the drug delivery device. On the other hand, when performing cross-linking surgery to treat corneal ectasia, the posterior surface of the peripheral area changes from a plane to an arc surface with a certain curvature, and the stable connection between the fixation device and the drug delivery device can still be guaranteed.

[0079] It is understood that the first connecting part can also be a barb, a fishbone, etc., and the second connecting part can also be a barb, a fishbone, etc.

[0080] Furthermore, the drug delivery body (10) is provided with 3-5 hollow micropores.

[0081] Furthermore, the height of the drug delivery microneedle (8) is 0.5-0.8 mm, the diameter of the needle tail is 0.7-0.9 mm, the distance between the needle tails is 0.08-0.12 mm, and the diameter of the needle tip is 0.5-0.7 mm.

[0082] Furthermore, the angle between the tangents at the contact point between the drug delivery microneedle (8) and the drug delivery body (10) is 90°. o .

[0083] The angle between the tangent at the contact point between the drug delivery microneedle and the drug-loaded substrate in this invention is 90°. o It facilitates the penetration of drugs into the corneal stroma.

[0084] Furthermore, in some embodiments of the present invention, the material of the fixing device (1) includes, but is not limited to, at least one of fluorosilyl polymer, polymethyl methacrylate, silicone hydrogel, and polyurethane.

[0085] Furthermore, the material of the drug delivery device (2) includes, but is not limited to, at least one of polylactic acid, polyhydroxyalkanoate, and polylactic acid-hydroxyacetic acid copolymer.

[0086] The fixation device and drug delivery device of this invention use different materials. The drug delivery device is made of non-toxic material that will not harm the eye after degradation in the eye, and its degradation rate is relatively fast. When applied to the treatment of corneal ectasia, it will completely degrade within 10-30 minutes. The fixation device is also made of non-toxic material that will not harm the eye after degradation in the eye. However, compared to the material of the drug delivery device, the material of the fixation device degrades more slowly. When applied to the treatment of corneal ectasia, it will degrade in 7 days to 1 month. The degradation rate can be controlled according to the patient's corneal mechanical changes. Therefore, the fixation device can remain in the eye for a longer period of time to exert a therapeutic effect. The fixation microneedles of the fixation device prevent further corneal expansion and thinning by applying force to the corneal surface, reducing corneal curvature to inhibit the progression of corneal thinning, shortening the arc length of the corneal thinning area, and reducing abnormal corneal refractive power.

[0087] The second aspect of this invention provides a method for preparing a personalized corneal contact lens microneedle device for the treatment of corneal ectasia, comprising the following steps:

[0088] S1. Obtain the different corneal morphological parameters of each person, and based on the corneal morphological parameters, make a personalized drug delivery device (2) mold by 3D printing for the range of corneal thinning area;

[0089] S2. Melt the material used to prepare the drug delivery device (2), heat it to 150℃-160℃, pour it into the mold of the drug delivery device (2), remove the air bubbles, cool and solidify, and obtain the drug delivery device (2) after demolding.

[0090] S3. Use 3D printing technology to print the fixing device (1), and then light-cur and clean it to obtain the fixing device (1).

[0091] S4. The drug delivery device (2) and the fixation device (1) are tightly connected and cleaned and disinfected to obtain a corneal contact lens microneedle device for the treatment of corneal ectasia.

[0092] This invention obtains corneal morphological parameters and uses them to 3D print a drug delivery device mold. This allows for the creation of personalized corneal contact lens microneedles based on the different shapes and characteristics of corneal dilation or thinning in different patients, as well as the location of corneal lesions. This results in a tighter fit between the corneal contact lens microneedle device and the corneal collagen cross-linking treatment site, which can better prevent the progression and deterioration of patients with dilated corneal disease, delay surgical treatment, and achieve the best therapeutic effect.

[0093] This invention uses a 3D data scanner and other medical ophthalmic examination instruments to scan the patient's ocular surface, and uses corneal topography and anterior segment OCT to obtain and calculate corneal morphological parameters, thereby obtaining the patient's corneal morphological characteristics (including key parameters such as corneal shape, central and peripheral corneal diameter, thickness, radius of curvature, base curve, and height loss). Then, a drug delivery device mold for a personalized corneal contact lens microneedle device for the treatment of corneal ectasia is made by 3D printing, which conforms to the corneal morphological characteristics. A fixation device is also made by 3D printing.

[0094] Further, in S3, the cleaning specifically involves immersing the fixing device (1) in an isopropanol solution after photocuring to remove uncured resin and deposits.

[0095] Furthermore, in S4, the disinfection is performed using ethylene oxide.

[0096] Furthermore, in S4, before the drug delivery device (2) and the fixing device (1) are fitted together, the drug delivery device (2) and the fixing device (1) are cut, cleaned, and polished.

[0097] Figure 4 The microstructure characterization and penetration capability test results of the drug delivery microneedles. From Figure 4 It can be seen that the drug delivery microneedle is small, has a hollow channel inside, and can effectively penetrate agar. After penetration, the needle body did not deform, indicating good penetration power.

[0098] Figure 5 The dissolution of drug delivery microneedles within 30 minutes after contact with artificial tears. From Figure 5 It can be seen that the drug delivery microneedles gradually dissolve after 10 minutes, and the drug can still be dripped at this time, delivered to the corneal stroma through the hollow microneedles, and the microneedles completely dissolve within 30 minutes.

[0099] Figure 6 To test the penetration capability of drug delivery microneedles in corneal tissue. Figure 6 As can be seen, the drug delivery microneedles effectively and minimally invasively penetrated the corneal epithelium and reached the corneal stroma. One day after the removal of the drug delivery microneedles, the structure of the corneal epithelium and stroma gradually recovered, and three days later, the corneal epithelium and stroma had basically returned to their original state. Here, 'a' represents that after the drug delivery microneedles acted on the cornea, they could effectively penetrate to the corneal stroma and deliver the drug to it; 'b' represents that one day after the drug delivery microneedles dissolved, the corneal stroma had returned to its normal structure; and 'c' represents that three days after the drug delivery microneedles dissolved, both the corneal epithelium and corneal stroma had fully recovered to their normal structure.

[0100] Figure 7To investigate the in vivo biosafety and efficacy of a personalized corneal contact lens microneedle device for the treatment of corneal ectasia. Figure 7 As can be seen, after using the microneedle corneal contact lens device, the corneal transparency was consistent with the blank control group, and no corneal damage or opacity was observed. Furthermore, the corneal curvature of the same mouse decreased before and after treatment. The blank control represents the cornea without any intervention; the corneal contact lens microneedle device represents the cornea that was transparent and smooth after microneedling, with no obvious damage; the pre-treatment image shows the corneal morphology before contact lens treatment; and the post-treatment image shows the decrease in corneal curvature and inhibition of convexity after contact lens treatment.

[0101] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of this utility model and not to limit it. Although the utility model has been described in detail with reference to the above embodiments, those skilled in the art should understand that after reading this application specification, they can still modify or make equivalent substitutions to the specific implementation of this utility model, but these modifications or changes do not depart from the protection scope of the pending claims of this utility model application.

Claims

1. A personalized corneal contact lens microneedle device for the treatment of corneal ectasia, characterized in that, include: A drug delivery device includes a drug delivery body and a drug delivery microneedle disposed on the drug delivery body; A fixing device is arranged around the outer periphery of the drug delivery body and concentrically with and fitted into the drug delivery body; The fixation device is used to fix the drug delivery body to the corneal thinning area, and the drug delivery microneedle is used to penetrate the corneal epithelium to reach the corneal stroma, so that the drug on the drug delivery body can penetrate into the corneal stroma. Combined with ultraviolet light irradiation, it can achieve the therapeutic effect of increasing the thickness and hardness of the cornea in the thinning area.

2. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 1, characterized in that, The fixation device includes a peripheral area for adhering to the corneal surface to fix the personalized corneal contact lens microneedle device to the corneal surface.

3. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 2, characterized in that, The fixation device also includes fixation microneedles disposed on the peripheral area. The fixation microneedles are used to penetrate the corneal epithelium and the superficial stroma to fix the corneal contact lens device, so that the fixation area is closely attached to the corneal surface around the thinned corneal area. The fixation microneedles and the fixation area control the corneal curvature through biomechanical action in the periphery of the cornea.

4. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 3, characterized in that, The shape of the fixed microneedles includes, but is not limited to, "pine tree shape" or "arrow shape".

5. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 3, characterized in that, The peripheral region includes a first posterior surface facing the corneal surface and an anterior surface facing away from the corneal surface, wherein the first posterior surface is planar and the anterior surface is curved.

6. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 3, characterized in that, The peripheral area includes a connecting area, a fixing area, and an edge area arranged sequentially from the direction closest to the drug delivery body to the direction furthest from the drug delivery body. The connecting area is connected to the drug delivery body, and the fixing microneedles are disposed in the fixing area.

7. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to claim 6, characterized in that, The fixation area further includes a second posterior surface facing the corneal surface, on which the fixation microneedle is disposed. The angle between the tangent of the contact point of the second posterior surface and the needle body of the fixation microneedle is ≤90°. o .

8. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to any one of claims 1 to 7, characterized in that, The drug delivery body is provided with a first micropore, and the drug delivery microneedle is provided with a second micropore, a liquid channel and a third micropore connected in sequence from the needle tail to the needle tip. The needle tail of the drug delivery microneedle is connected to the drug delivery body so that the second micropore is connected to the first micropore. When the needle tip of the drug delivery body penetrates to the corneal stroma, the third micropore is used to permeate the drug into the corneal stroma.

9. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to any one of claims 1 to 7, characterized in that, The drug delivery body is provided with a first connecting part, and the fixing device is provided with a second connecting part. The second connecting part is connected to the first connecting part to connect the fixing device to the drug delivery device.

10. The personalized corneal contact lens microneedle device for the treatment of corneal ectasia according to any one of claims 1 to 7, characterized in that, The materials of the fixation device include, but are not limited to, at least one of fluorosilicone polymers, polymethyl methacrylate, silicone hydrogels, and polyurethane; The materials of the drug delivery device include, but are not limited to, at least one of polylactic acid, polyhydroxyalkanoate, and polylactic acid-glycolic acid copolymer.

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