Matrix lens corneal donors based on hydrogel bonding

Abstract

The utility model relates to a matrix lens corneal donor based on hydrogel bonding, and the corneal donor comprises a plurality of layers of corneal matrix lenses which are stacked along the thickness direction of the corneal matrix lenses; and the bonding layer is bonded between two adjacent cornea stroma lenses, and the bonding layer comprises composite material hydrogel which forms a grid porous structure after being cured. The stacked multiple layers of cornea stroma lenses are bonded to the preset thickness through the combined adhesive, so that the cornea donor has high structural strength, the problem of sliding or twisting deformation in the surgical suture process is effectively avoided, a grid porous structure is formed after composite hydrogel is cured, and the cornea donor has a good application prospect. The air permeability and the structural strength of the matrix lens cornea donor based on hydrogel bonding are guaranteed, and the reliability of cornea repair is improved.

Description

Technical Field

[0001] This disclosure relates to the field of corneal transplantation technology, and more specifically, to a stromal lenticule corneal donor based on hydrogel bonding. Background Technology

[0002] Due to the extreme scarcity of corneal donors, the number of corneal transplant surgeries is very limited. Most early-stage corneal diseases do not involve the entire corneal layer. While lamellar resection of the lesion combined with medication can partially control infection, it does not achieve completely satisfactory postoperative results. Problems include thin corneal tissue leading to irregular astigmatism, corneal scarring affecting vision, and difficulty in completely removing deep lesions to control infection. Among related techniques, SMILE stromal lenticule transplantation is used to treat corneal stromal defects or perforations. However, during the surgical suturing process, the thinness and instability of the single-layer corneal stromal lenticule make it prone to slippage and distortion. Furthermore, uneven stress at the edges significantly reduces the precision of the graft, resulting in inconsistent angularity. These problems not only cause postoperative astigmatism but may also lead to graft opacity, affecting vision. In addition, its biomechanical strength is insufficient for practical clinical needs. Utility Model Content

[0003] The purpose of this disclosure is to provide a stromal lenticule corneal donor based on hydrogel bonding, so as to at least partially solve the technical problems existing in the related art.

[0004] To achieve the above objectives, this disclosure provides a stromal lenticule corneal donor based on hydrogel bonding, the corneal donor comprising:

[0005] Multilayer corneal stromal lenses, stacked along their thickness direction; and

[0006] An adhesive layer is bonded between two adjacent corneal stromal lenses, the adhesive layer comprising a composite hydrogel having a mesh-porous structure after curing.

[0007] Optionally, the composite hydrogel is a polyacrylamide sodium acrylate hydrogel.

[0008] Optionally, the light transmittance of the adhesive layer is 94% or higher.

[0009] Optionally, the tensile modulus of the adhesive layer is 2~2.1 kPa and the compressive modulus is 7.5~8.5 kPa.

[0010] Optionally, the adhesive force of the adhesive layer is 2~2.2 kPa.

[0011] Optionally, the composite hydrogel is a double cross-linked network hydrogel.

[0012] Optionally, the thickness of the multiple corneal stromal lenses is the same.

[0013] Optionally, the two adjacent corneal stromal lenses are completely adhered to each other.

[0014] Optionally, the outer contour edges of the corneal stromal lenses in each layer are aligned.

[0015] The above technical solution uses a combined adhesive to bond stacked multilayer corneal stromal lenses to a preset thickness, giving the corneal donor strong structural strength and effectively avoiding slippage or torsion deformation during surgical suturing. After the composite hydrogel cures, a mesh porous structure is formed, ensuring the air permeability and structural strength of the hydrogel-bonded stromal lens corneal donor and improving the reliability of corneal repair.

[0016] Other features and advantages of this disclosure will be described in detail in the following detailed description section. Attached Figure Description

[0017] The accompanying drawings are provided to further illustrate the present disclosure and form part of the specification. They are used together with the following detailed description to explain the present disclosure, but do not constitute a limitation thereof. In the drawings:

[0018] Figure 1 This is a diagram illustrating the combination of a corneal donor and a cornea to be repaired, provided in an exemplary embodiment of this disclosure.

[0019] Figure 2 This is a schematic diagram of the structure of a corneal donor provided in an exemplary embodiment of this disclosure;

[0020] Figure 3 This is a schematic diagram of a multilayer corneal stromal lens stack provided by an exemplary embodiment of this disclosure.

[0021] Explanation of reference numerals in the attached figures

[0022] 1-Corneal donor; 11-Corneal stromal lenticule; 2-Cornea to be repaired; 21-Groove. Detailed Implementation

[0023] The specific embodiments of this disclosure will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit this disclosure.

[0024] In this disclosure, unless otherwise stated, directional terms such as "inner" and "outer" refer to the outline of the corresponding component itself; directional terms such as "upper" and "lower" are defined based on the usage conventions of the hydrogel-bonded stromal lenticule corneal donor provided in this disclosure. Specifically, refer to... Figure 1 The orientation of the diagram is shown.

[0025] Reference Figures 1-3 This disclosure provides a hydrogel-bonded stromal lenticule corneal donor, the corneal donor 1 of which may include a multilayer corneal stromal lenticule 11 and an adhesive layer. For example... Figure 2 and Figure 3 As shown, the multilayer corneal stromal lenticule 11 can be stacked along its thickness direction to achieve a preset thickness, thereby improving the structural strength of the corneal donor 1. During subsequent transplantation, the corneal donor 1 can be processed and reshaped to meet the different needs of the patient, improving the adaptability of the corneal donor 1. The thickness direction in this disclosure refers to... Figure 1 The diagram shows the vertical direction. Furthermore, this disclosure does not limit the specific number of layers of the multilayer corneal stromal lens 11; they can be stacked according to clinical needs. An adhesive layer can be bonded between two adjacent corneal stromal lenses 11, and the adhesive layer includes a composite hydrogel that forms a mesh-like porous structure after curing. The composite hydrogel in this disclosure is a biocompatible medical adhesive that can act as an adhesive or binder to biological tissue during surgical suturing and tissue bonding. Upon contact with biological tissue, i.e., the corneal stromal lens 11 or the cornea to be repaired 2, the composite hydrogel can undergo a polymerization reaction with the biological tissue, thereby bonding the layers of the corneal stromal lens 11 together or binding it to the cornea to be repaired 2. Figure 1 As shown, a groove 21 can be formed at the lesion site of the cornea 2 to be repaired. The corneal donor 1 can be filled in the groove 21. Through the polymerization of the adhesive layer with the cornea 2 to be repaired, the corneal donor 1 is bonded to the cornea to be repaired, thereby repairing the cornea 2. The composite hydrogel forms a mesh-like porous structure after curing, which not only allows the moisture in the adhesive layer to be retained for a long time, but also enhances the mechanical properties of the adhesive layer. In this disclosure, when forming the corneal donor 1, a layer of corneal stromal lens 11 can be fully unfolded first, then unpolymerized liquid of composite hydrogel can be dripped on, and then another layer of corneal stromal lens 11 can be covered, and the surface can be flattened with tweezers to remove air bubbles. The above operation is repeated until the multiple layers of corneal stromal lenses 11 are stacked to the required thickness.

[0026] Through the above technical solution, the adhesive layer bonds the stacked multilayer corneal stromal lens 11 to a preset thickness, so that the corneal donor 1 has strong structural strength, effectively avoiding the problem of slippage or torsion deformation during surgical suturing. After the composite hydrogel is cured, a grid porous structure is formed, which ensures the air permeability and structural strength of the stromal lens corneal donor based on hydrogel bonding, and improves the reliability of corneal repair.

[0027] In the embodiments provided in this disclosure, the composite hydrogel can be a polyacrylamide-sodium acrylate hydrogel, so that the corneal donor 1 has good flexibility and elasticity to adapt to corneal movement and deformation, and at the same time, it is also conducive to the growth and repair of corneal cells. According to the embodiments provided in this disclosure, the raw materials of the composite hydrogel may include a polyacrylamide-sodium acrylate hydrogel of acrylamide and sodium acrylate, and acrylamide and sodium acrylate can be bonded by N,N'-methylenebisacrylamide to form a polyacrylamide-sodium acrylate hydrogel. The molar ratio between acrylamide, sodium acrylate and N,N'-methylenebisacrylamide can be 174:25:1.

[0028] In the embodiments provided in this disclosure, the transmittance of the adhesive layer is above 94%, which can effectively prevent problems such as blurred vision and astigmatism in the patient after the cornea to be repaired 2 is combined with the corneal donor 1, thus ensuring the patient's visual quality. In addition, by making the adhesive layer have good transmittance, it is also possible to ensure that the doctor can clearly observe the suture site during the relevant surgical suturing process, thus ensuring the accuracy and safety of the operation.

[0029] In the embodiments provided in this disclosure, the tensile modulus of the adhesive layer can be 2~2.1 kPa, for example, 2.07 kPa, and the compressive modulus can be 7.5~8.5 kPa, for example, 8 kPa, thereby ensuring that the adhesive layer has good fatigue performance, improving the service life of the corneal donor 1, ensuring the long-term stability of the surgical effect, avoiding secondary surgery, and preventing greater pain and risks to the patient.

[0030] In the embodiments provided in this disclosure, the adhesive force of the adhesive layer can be 2~2.2 kPa, for example, 2.1 kPa, so as to meet the adhesion requirements between the corneal stromal lenses 11 and ensure the adhesion strength between the corneal donor 1 and the groove 21 when the corneal donor 1 is transplanted into the groove 21.

[0031] In the embodiments provided in this disclosure, the composite hydrogel can be a dual-crosslinked network hydrogel. This dual-crosslinked network hydrogel can be a GelMA / HA-NB dual-network hydrogel whose raw materials include methacrylated gelatin and butyramide-modified glycosaminoglycan hyaluronic acid. The dual-crosslinked network hydrogel can undergo a crosslinking reaction with a curing agent under light to form a three-dimensional interpenetrating network structure, thereby providing support for cell growth and tissue repair.

[0032] Reference Figures 1-2The thickness of the multilayer corneal stromal lenticule 11 can be uniform to ensure that when the corneal donor 1 is subjected to external force, the stress can be evenly distributed on each layer of the corneal stromal lenticule 11, preventing any one layer of the corneal stromal lenticule 11 from bearing excessive stress and failing first. This allows the corneal donor 1 to withstand external force more evenly, improving the overall strength and stability. In the embodiments provided in this disclosure, the corneal stromal lenticule 11 can be removed from the cornea that provides the corneal stromal lenticule 11 through a femtosecond laser micro-incision corneal stromal lenticule extraction procedure, and the thickness of the corneal stromal lenticule 11 can be 60-150 μm.

[0033] Reference Figure 1 and Figure 2 In this invention, the two adjacent corneal stromal lenticules 11 of the corneal donor 1 are completely adhered to each other. It is understood that "completely adhered to each other" in this disclosure means that the two adjacent corneal stromal lenticules 11 can achieve maximum contact, both macroscopically and microscopically. For example, when one corneal stromal lenticule 11 is a curved surface, such as part of a sphere, the other corneal stromal lenticule 11 that is completely adhered to it also has the same curvature, and one of them can perfectly cover the other without any local lifting or gaps. In this way, during the suturing process, when the corneal donor 1 is stretched, the two adjacent corneal stromal lenticules 11 will elongate synchronously, without relative slippage or delamination. This effectively improves the corneal donor 1's resistance to deformation while ensuring its tensile performance. In addition, the two fully fitted corneal stromal lenses 11 can ensure the continuity of light propagation, thereby effectively avoiding adverse optical phenomena such as light scattering and reflection caused by unevenness or gaps between the multiple corneal stromal lenses 11.

[0034] Reference Figures 1-3 The outer contour edges of each layer of corneal stromal lenticule 11 in the corneal donor 1 are aligned. It can be understood that the outer contour edges of each layer of corneal stromal lenticule 11 are also aligned in the direction perpendicular to the plane of the corneal stromal lenticule 11, and the outer contour edges of each layer of corneal stromal lenticule 11 coincide in the vertical direction. Here, the vertical direction refers to... Figure 1 The orientation of the diagram is shown. For example, when the corneal stromal lens 11 is circular, each layer of corneal stromal lens 11 is concentric and their circumferences completely overlap. This design ensures that the corneal donor 1 has good dimensional stability, effectively avoiding the problem of single-layer corneal stromal lens 11 twisting and deforming during the suturing of the corneal donor 1 and the cornea to be repaired 2. In the embodiments provided in this disclosure, after the multiple layers of corneal stromal lenses 11 are removed from other donor corneas and stacked on top of each other, they can present the following arrangement: Figure 2As shown in the diagram, the corneal donor 1 can then be formed by trephine cutting to a predetermined size. In clinical use, the corneal donor 1 can be reshaped using femtosecond laser micro-incision lenticule extraction to meet the clinical requirements for shape, thickness, and refractive power, depending on the patient's specific situation.

[0035] The preferred embodiments of this disclosure have been described in detail above with reference to the accompanying drawings. However, this disclosure is not limited to the specific details of the above embodiments. Within the scope of the technical concept of this disclosure, various simple modifications can be made to the technical solutions of this disclosure, and these simple modifications all fall within the protection scope of this disclosure.

[0036] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, this disclosure will not describe the various possible combinations separately.

[0037] Furthermore, various different embodiments of this disclosure can be combined in any way, as long as they do not violate the spirit of this disclosure, they should also be regarded as the content disclosed in this disclosure.

Claims

1. A stromal lenticule corneal donor based on hydrogel bonding, characterized in that, The corneal donor includes: Multilayer corneal stromal lenses, stacked along their thickness direction; and An adhesive layer is bonded between two adjacent corneal stromal lenses, the adhesive layer comprising a composite hydrogel having a mesh-porous structure after curing.

2. The stromal lenticule corneal donor based on hydrogel bonding according to claim 1, characterized in that, The composite hydrogel is a polyacrylamide sodium acrylate hydrogel.

3. The hydrogel-bonded stromal lenticule corneal donor according to claim 1 or 2, characterized in that, The light transmittance of the adhesive layer is above 94%.

4. The stromal lenticule corneal donor based on hydrogel bonding according to claim 1 or 2, characterized in that, The tensile modulus of the adhesive layer is 2~2.1 kPa, and the compressive modulus is 7.5~8.5 kPa.

5. The hydrogel-bonded stromal lenticule corneal donor according to claim 1 or 2, characterized in that, The adhesive force of the adhesive layer is 2~2.2 kPa.

6. The stromal lenticule corneal donor based on hydrogel bonding according to claim 1, characterized in that, The composite hydrogel is a double cross-linked network hydrogel.

7. The stromal lenticule corneal donor based on hydrogel bonding according to claim 1, characterized in that, The thickness of the multilayer corneal stromal lens is the same.

8. The stromal lenticule corneal donor based on hydrogel bonding according to claim 1, characterized in that, The two adjacent corneal stromal lenses are completely adhered to each other.

9. The hydrogel-bonded stromal lenticule corneal donor according to claim 1 or 8, characterized in that, The outer contour edges of the corneal stromal lenses in each layer are aligned.

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