Ophthalmic surgical device for sclera

Abstract

The present invention discloses an ophthalmic surgical device for sclera, comprising a manipulation module, a lifting control module and an arc-shaped shell, wherein the arc-shaped shell has a curvature and length adapted to the shape of the eyeball, and an open cavity is provided on one side of the arc-shaped shell for matching the sclera of the eyeball, wherein the lifting control module is installed in the open cavity, wherein the lifting control module is used to load and apply reinforcing materials and adhesive plasticizers to the sclera of the eyeball, wherein the manipulation module is connected to the lifting control module, and is used to manipulate the lifting control module to lift out of the open cavity to apply the reinforcing materials and adhesive plasticizers to the sclera of the eyeball, and manipulate the lifting control module to reset to the open cavity after the application is completed. The device of the present invention can attach the reinforcing materials to the surface of the posterior sclera through adhesive plasticizers in a minimally invasive, safe and accurately positioned manner, thereby achieving mechanical reinforcement of the posterior sclera, and enhancing constant pressure for the posterior pole or posterior scleral staphyloma.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic surgical devices, and in particular to an ophthalmic surgical device for sclera. Background Art

[0002] In recent years, the incidence of myopia has increased year by year worldwide. Pathological myopia refers to the patient's refractive power often exceeding 600 degrees, accompanied by a continuous increase in the axial length and a series of fundus lesions, which is particularly harmful to the vision of the population. Pathological myopia has the highest incidence among Asians. The number of patients with pathological myopia in my country is huge, causing a non-negligible socioeconomic burden. The research on the treatment of pathological myopia is of great significance. Previous studies have found that there is scleral collagen fiber remodeling in pathological myopia, which is specifically manifested in a significant reduction in scleral collagen and dissociation of fiber bundles, which weakens the mechanical strength of the sclera, which may be an important cause of the progressive elongation of the patient's axial length or the local expansion of the sclera to produce posterior scleral staphyloma. The tensile force of the sclera causes mechanical damage to the retina and choroid, while aggravating the fundus blood circulation disorder, promoting the occurrence of complications such as retinoschisis, macular hole, and retinal detachment, and ultimately seriously damaging the patient's vision. It can be seen that increasing the strength of the posterior sclera and controlling the expansion of the eyeball are important ideas for controlling pathological myopia.

[0003] Based on this idea, some studies have shown that posterior scleral reinforcement can increase the strength of the sclera, thereby delaying the axial length growth of patients with pathological myopia. This surgical method mostly uses allogeneic sclera to cover the back of the eyeball and fix it with sutures, which has not been widely recognized in clinical practice. The problems with this surgery include that the allogeneic sclera is taken from fresh cadaveric eyeballs, which are difficult to obtain and preserve, and there is a risk of infection; the surgical field is exposed to a large area and the surgical operation is complicated; local inflammatory reactions can easily cause adhesion of surrounding tissues, etc., which limits the application of surgery. Other studies have increased the strength of the sclera by activating riboflavin with ultraviolet rays to induce collagen cross-linking, but this method can only increase the connection between existing collagen fibers. Considering that the collagen content in the sclera of patients with pathological myopia is reduced and the distance between collagen fibers is increased, it may affect the treatment effect. In addition, ultraviolet radiation, coupled with the photochemical reaction in the sclera, is very close to the retina, and the oxygen free radicals produced may cause damage to the retinal nerve function. The safety of the treatment has not yet been confirmed, and this treatment method has not yet entered clinical application.

[0004] It should be noted that the information disclosed in the above background technology section is only used for understanding the background of the present application, and therefore may include information that does not constitute prior art known to ordinary technicians in the field. Summary of the invention

[0005] The main purpose of the present invention is to overcome the defects of the above-mentioned background technology and to provide an ophthalmic surgical device for the sclera, which can minimally invasively, safely, and accurately position the reinforcement material to the surface of the posterior sclera through an adhesive plasticizer, integrate material shaping and light curing operations, achieve mechanical reinforcement of the posterior sclera, and enhance pressure stabilization for the posterior pole or posterior scleral staphyloma.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] An ophthalmic surgical device for sclera, comprising a manipulation module, a lifting control module and an arc-shaped shell, wherein the arc-shaped shell has a curvature and a length adapted to the shape of the eyeball, and an open cavity is provided on one side of the arc-shaped shell for matching the sclera of the eyeball, wherein the lifting control module is installed in the open cavity, wherein the lifting control module is used to load and apply reinforcing materials and adhesive plasticizers to the sclera of the eyeball, wherein the manipulation module is connected to the lifting control module, and is used to manipulate the lifting control module to lift out of the open cavity so as to apply the reinforcing materials and adhesive plasticizers to the sclera of the eyeball, and manipulate the lifting control module to return to the open cavity after the application is completed.

[0008] In some embodiments, the lifting control module includes a retractable and deformable lifting mechanism and an elastic lining plate. The lifting mechanism is connected to the operating module. The lining plate is arranged on the lifting mechanism. The adhesive plasticizer and the reinforcement material are loaded on the lining plate. The lining plate is in an arc-shaped and flat state in the initial state. The lifting mechanism produces a telescopic change under the control of the operating module. When the lifting mechanism contracts, the height is raised, causing the lining plate to produce a centripetal bulging bending deformation. When the lifting mechanism extends, the height is reduced, and the lining plate returns to a flat state.

[0009] In some embodiments, the lifting mechanism is connected to the lining plate via a plurality of fixed fulcrums, and the plurality of fixed fulcrums limit the deformation area of ​​the lining plate that is centripetally raised; preferably, the plurality of fixed fulcrums include a plurality of fixing members, a plurality of adjustment grooves provided on the lining plate, and a plurality of connecting holes provided on the lifting mechanism, and each fixing member passes through the corresponding adjustment groove and connecting hole to fix the lifting mechanism to the lining plate, and the adjustment groove is used to pre-adjust the position of the fixing member to achieve adjustment of the position and size of the deformation area of ​​the lining plate.

[0010] In some embodiments, the lifting mechanism and the lining plate are further provided with a sliding pair at a position outside the deformation area, and are slidably connected via the sliding pair, and the sliding pair is provided along the direction of telescopic deformation of the lifting mechanism.

[0011] In some embodiments, the lifting mechanism and / or the lining plate is made of polylactic acid. Preferably, the surface of the lining plate has anti-sticking texture. Preferably, the surface of the lining plate is provided with a polyethylene layer and coated with silicone oil as an anti-sticking release layer.

[0012] In some embodiments, the lifting mechanism includes a chain structure formed by a plurality of deformable polygonal repeating elements connected in series.

[0013] In some embodiments, the invention further comprises a cover plate which is openably and closably arranged on the open cavity, and the operating module is further connected to the cover plate to control the opening and closing of the cover plate.

[0014] In some embodiments, the operating module includes a handle, a lifting mechanism retractable handle, a Bowden cable, a Bowden tube and a return spring. The arc-shaped shell is connected to the handle, and the lifting mechanism retractable handle is installed on the handle. One end of the Bowden cable is connected to the lifting mechanism retractable handle, and the other end of the Bowden cable is connected to the distal end of the lifting mechanism. One end of the Bowden tube is against the proximal end of the lifting mechanism, and the other end of the Bowden tube is fixed to the handle. A reserved hole is provided on the handle, and the return spring is placed in the reserved hole. The lifting mechanism retractable handle is limited in the reserved hole and is located on the return spring. A pulley is provided in the reserved hole, and the Bowden cable is connected to the lifting mechanism retractable handle through the pulley.

[0015] In some embodiments, the lifting control module and / or the arc-shaped housing is provided with a searchlight.

[0016] In some embodiments, the adhesive plasticizer is photocurable, and the lifting control module and / or the arc-shaped shell is provided with a photocuring light source; preferably, the adhesive plasticizer is a tissue glue of hydrogel or collagen component, preferably an elastin-like polypeptide modified with a methacrylate group or a polyethylene glycol diacrylate gel; the reinforcement material is a biocompatible polymer film, preferably a polylactic acid electrospun film; preferably, the reinforcement material is a layered asymmetric structure, each layer having different pore sizes and mechanical strengths; preferably, the sclera bonding surface of the reinforcement material is rough to facilitate adhesion and cell proliferation, and the other side of the reinforcement material is a smooth surface to inhibit adhesion of surrounding tissues.

[0017] The present invention has the following beneficial effects:

[0018] The ophthalmic surgical device described in the present invention is designed with an arc-shaped shell with a curvature and length that are adapted to the shape of the eyeball. The lifting control module installed in the open cavity of the arc-shaped shell is lifted by a manipulation module, and the reinforcement material and adhesive plasticizer loaded on the lifting control module are lifted up and attached to the scleral surface of the eyeball. The reinforcement material can be attached to the posterior scleral surface through the adhesive plasticizer in a minimally invasive, safe and accurately positioned manner. The reinforcement material and adhesive plasticizer are used to mechanically reinforce the posterior scleral area and to increase the constant pressure at the posterior pole or the location of the posterior scleral staphyloma.

[0019] In addition, by using reinforcement materials and adhesive plasticizers with good mechanical strength and adhesion strength, a microenvironment suitable for cell migration and proliferation is provided, scleral fibroblasts are induced to migrate, proliferate, and produce new collagen to achieve biological reinforcement of the sclera, thereby controlling the expansion of the posterior sclera and reducing the long-term effect of related fundus lesions, and it is used to treat complications related to progressive elongation of the axial length of high myopia and posterior scleral staphyloma. Compared with the allogeneic sclera commonly used for scleral reinforcement, the device described in the present invention integrates the operations of positioning, placing reinforcement materials and adhesive plasticizers, and curing and shaping. Moreover, the reinforcement materials and adhesive plasticizers are fixed, free from suturing, and cause weak inflammatory reactions in the body, are not easy to cause adhesion of surrounding tissues, can be completely degraded in a certain period of time, and the degradation products are harmless to the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 A schematic diagram of the specific structure of an ophthalmic surgical device for sclera provided in an embodiment of the present invention;

[0021] Figure 2 for Figure 1 A partial enlarged schematic diagram of the end of the cover plate in the open state;

[0022] Figure 3 for Figure 1 Schematic diagram of partial decomposition of the tail end;

[0023] Figure 4 A schematic diagram of a lining plate in a lifting control module provided by an embodiment of the present invention;

[0024] Figure 5 A schematic diagram of a lining plate and a lifting mechanism sliding pair in a lifting control module provided in an embodiment of the present invention;

[0025] Figure 6 A schematic diagram of the lifting control module provided by an embodiment of the present invention being retracted and lifted;

[0026] Figure 7 A schematic diagram of the structure of the ophthalmic surgical device for sclera provided by an embodiment of the present invention applied to the patient's eyeball;

[0027] Reference numerals:

[0028] 1. Operating module; 10. Handle; 11. Cover plate retracting handle; 12. Lifting mechanism retracting handle; 13. Bowden cable; 14. Return spring; 15. Pulley; 16. Bowden tube; 17. Boss; 18. Slide 1; 19. Slide 2; 121. Slide key; 131. Bowden cable fixed end 1; 132. Bowden cable fixed end 2; 161. Bowden tube A end; 162. Bowden tube B end;

[0029] 2. Lifting control module; 21. Lifting mechanism; 22. Lining plate; 23. Fixed fulcrum; 24. Sliding pair; 25. Light curing light source; 26. Searchlight; 221. Lining plate deformation area; 222. Adjustment slot; 241. Slide rail; 242. Sliding block;

[0030] 3. curved housing; 31. cover plate; 32. open cavity;

[0031] 4. Reinforcement materials;

[0032] 5. Patient's eyeball; 51. Superior rectus muscle; 52. Optic nerve; 53. Lateral rectus muscle. DETAILED DESCRIPTION

[0033] The following is a detailed description of the embodiments of the present invention. It should be emphasized that the following description is only exemplary and is not intended to limit the scope and application of the present invention.

[0034] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element. In addition, connection can be used for fixing as well as for coupling or communication.

[0035] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0036] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0037] The background section of the present invention may contain background information about the problem or environment of the present invention, but does not necessarily describe the prior art. Therefore, the content included in the background section is not an admission by the applicant that the prior art is available.

[0038] like Figure 1 , Figure 2 and Figure 7 As shown, an ophthalmic surgical device for sclera includes a manipulation module 1, a lifting control module 2 and an arc-shaped shell 3, wherein the arc-shaped shell 3 has a curvature and a length adapted to the shape of an eyeball 5, and the curvature and the length of the arc-shaped shell 3 are customized according to the shape of the operated eye, and an open cavity 32 is provided on one side of the arc-shaped shell 3 for matching the sclera of the eyeball, wherein the lifting control module 2 is installed in the open cavity 32, wherein the lifting control module 2 is used for loading and applying a reinforcing material 4 and an adhesive plasticizer to the sclera of the eyeball, wherein the manipulation module 1 is connected to the lifting control module 2, and is used for manipulating the lifting control module 2 to lift out of the open cavity 32 so as to apply the reinforcing material 4 and the adhesive plasticizer to the sclera of the eyeball, and manipulating the lifting control module 2 to return to the open cavity 32 after the application is completed.

[0039] During the operation, the arc-shaped shell 3 can be extended to one side of the posterior sclera of the eyeball 5, and the lifting control module 2 installed in the open cavity 32 of the arc-shaped shell 3 can be lifted by the operating module 1, so that the reinforcement material 4 and the adhesive plasticizer loaded on the lifting control module 2 can be lifted and attached to the surface of the sclera of the eyeball. In this way, the reinforcement material 4 can be attached to the surface of the posterior sclera through the adhesive plasticizer in a minimally invasive, safe and accurately positioned manner. The posterior sclera area is mechanically reinforced by the reinforcement material 4 and the adhesive plasticizer, and the posterior pole or the posterior scleral staphyloma is strengthened. The good mechanical strength and adhesion strength of the reinforcement material and the adhesive plasticizer are utilized to provide a microenvironment suitable for cell migration and proliferation, thereby inducing scleral fibroblasts to migrate, proliferate and produce new collagen to achieve biological reinforcement of the sclera, thereby achieving the long-term effect of controlling the expansion of the posterior sclera and reducing related fundus lesions.

[0040] like Figure 2As shown, the lifting control module 2 includes a lifting mechanism 21 that can be retracted and deformed and an elastic lining plate 22. The lifting mechanism 21 is connected to the operating module 1. The lining plate 22 is arranged on the lifting mechanism 21. The adhesive plasticizer and the reinforcing material 4 are loaded on the lining plate 22. The lining plate 22 is in an arc-shaped flat state in the initial state. The lifting mechanism 21 produces a retractable change under the control of the operating module 1. When the lifting mechanism 21 contracts, the height is lifted, so that the lining plate 22 produces a centripetal bulge bending deformation, which can achieve the dual effects of extensive reinforcement of the posterior scleral area and strengthening the top pressure on the posterior scleral staphyloma position. When the lifting mechanism 21 is extended, the height is reduced, and the lining plate 22 returns to a flat state.

[0041] like Figure 2 and Figure 6 As shown, the lifting mechanism 21 is connected to the lining plate 22 via a plurality of fixed fulcrums 23, and the plurality of fixed fulcrums 23 limit the deformation area of ​​the lining plate 22 that is centripetally raised; preferably, the plurality of fixed fulcrums 23 include a plurality of fixing members, a plurality of adjustment grooves arranged on the lining plate 22, and a plurality of connecting holes arranged on the lifting mechanism 21, and each fixing member passes through the corresponding adjustment groove 222 and the connecting hole to fix the lifting mechanism 21 to the lining plate 22, and the adjustment groove 222 is used to pre-adjust the position of the fixing member to achieve the adjustment of the position and size of the deformation area of ​​the lining plate 22.

[0042] Preferably, the fixed fulcrum 23 is an independent component, and its structure is similar to a flat-headed nail, which is a non-standard part. During installation, the flat-headed nail is inserted from the pre-processed adjustment groove on one side of the liner 22, and at the same time, is inserted into the reserved hole of the lifting mechanism 21 behind the liner 22. In terms of the matching relationship, the flat-headed nail and the liner 22 are interference fit, and the flat-headed nail and the lifting mechanism 21 are interference fit. The initial state of the liner 22 is a semi-circular flat state. When the lifting mechanism 21 is contracted and lifted, the distance between the two pairs of fixed fulcrums in the long axis direction of the liner 22 is shortened. At the same time, the contraction of the lifting mechanism 21 applies an upward force to the liner 22 on its surface, so that the liner 22 between the fulcrums is bent and deformed, thereby bulging upward. Before the operation, the relative position of the liner 22 and the lifting mechanism 21 can be adjusted through the adjustment groove 222 on the liner 22, so as to adjust the position of the deformation area 221 of the liner to match the position of the lesion of the surgical eye and meet personalized needs.

[0043] like Figure 5As shown, two rectangular slots are machined at both ends of the lining plate 22, a slide rail 241 is machined on each inner wall on both sides of the long axis direction of the slot (the slide rail 241 is arranged on the inner wall of the slot), and a slider 242 is machined on the top of the lifting mechanism 21. The lifting mechanism 21 and the lining plate 22 are also provided with a sliding pair 24 at a position outside the deformation area, and are connected in a slidable manner through the sliding pair 24, and the sliding pair 24 is arranged along the direction of the telescopic deformation of the lifting mechanism 21. The existence of the sliding pair 24 can limit the positional relationship between the two, prevent the lining plate 22 from falling off the lifting mechanism 21, and allow the lifting mechanism 21 and the lining plate 22 to slide relative to each other at a position outside the deformation area.

[0044] like Figure 4 As shown, the lifting mechanism 21 and / or the lining plate 22 are made of polylactic acid, the surface of the lining plate 22 has anti-sticking patterns (longitudinal corrugated stripes), and the surface of the lining plate 22 is provided with a polyethylene layer and coated with silicone oil as an anti-sticking release layer.

[0045] Wherein, the operating module 1 includes a handle 10, a lifting mechanism retractable handle 12, a Bowden cable 13, a Bowden tube 16 and a return spring 14, the arc-shaped housing 3 is connected to the handle 10, the lifting mechanism retractable handle 12 is installed on the handle 10, one end of the Bowden cable 13 is connected to the lifting mechanism retractable handle 12, the other end of the Bowden cable 13 is connected to the distal end of the lifting mechanism 21, one end of the Bowden tube 16 (Bowden tube A end 161) is against the proximal end of the lifting mechanism 21, and the other end of the Bowden tube (Bowden tube B end 162) is fixed on the handle, a reserved hole is provided on the handle 10, the return spring 14 is placed in the reserved hole, the lifting mechanism retractable handle 12 is limited in the reserved hole, and is located on the return spring 14, a pulley 15 is provided in the reserved hole, and the Bowden cable 13 is connected to the lifting mechanism retractable handle 12 through the pulley 15.

[0046] like Figure 1 , Figure 2 , Figure 3 and Figure 6As shown, the lifting mechanism 21 is connected to the lifting mechanism retractable handle 12 on the handle 10 through a Bowden cable 13, wherein the Bowden cable 13 passes through a pulley 15 fixed inside the handle 10, and the inner end of the handle of the lifting mechanism retractable handle 12 has a reset spring 14. By pressing the lifting mechanism retractable handle 12, the lifting mechanism 21 can be retracted and lifted, and the spring 14 can reset the lifting mechanism. One end of the Bowden cable 13 passes through the small hole at the bottom of the lifting mechanism retractable handle 12 and is connected to the Bowden cable fixed end 1131 through a set screw, and the other end passes through a hole that passes through the lifting mechanism 21 and is connected to the Bowden cable fixed end 2132. The A end 161 of the Bowden tube supports the lifting mechanism, and the B end 162 of the Bowden tube cooperates with the hole on the boss 17 inside the handle 10 (interference fit). As shown Figure 3 As shown, a spring 14 is placed in the reserved hole of the handle 10, and the Bowden cable 13, the Bowden cable fixed end 1131 and the lifting mechanism retractable handle 12 are installed and inserted into the slide groove 118 in the reserved hole of the handle 10. After the sliding key of the lifting mechanism retractable handle 12 is inserted into the bottom of the reserved hole of the handle 10 along the slide groove 118, the lifting mechanism retractable handle 12 is rotated (clockwise 15°) to align the sliding key 121 of the lifting mechanism retractable handle 12 with the slide groove 219 of the handle 10. The slide groove 219 is not conductive on the upper end surface of the handle 10, which can prevent the lifting mechanism retractable handle 12 from sliding out. A pulley-like structure is manufactured in the reserved hole of the handle 10 to guide the Bowden cable 13. The stable state of the lifting mechanism 21 is a flattened state of a semicircular arc. Due to the guiding effect of the pulley 15, the lifting mechanism retracting handle 12 can pull the Bowden cable 13, so that the Bowden tube A end 161 and the Bowden cable fixed end 2 161 exert a squeezing force on the lifting mechanism 21, causing it to retract and lift. Due to the existence of the spring 14, after the lifting mechanism retracting handle 12 is released, the lifting mechanism retracting handle 12 is reset, the traction force disappears, and the lifting mechanism 21 automatically resets.

[0047] like Figure 6 As shown, the lifting mechanism 21 includes a chain structure formed by a plurality of deformable polygonal repeating elements connected in series. The polygonal repeating element may be a substantially quadrilateral repeating element. The quadrilateral repeating element in a stable state is a flattened long strip (diagonal 0°), that is, the lifting mechanism 21 is flattened; pressing the lifting mechanism contraction handle 12 can pull the Bowden cable 13, so that the Bowden tube A end 161 and the fixed end 2 132 of the Bowden cable apply a squeezing force to the two ends of the lifting mechanism 21, and the repeating element is deformed into a quadrilateral with a diagonal of 30±5°, that is, the lifting mechanism 21 contracts and lifts up.

[0048] The cavity may further include a cover plate 31 which is openably and closably arranged on the open cavity, and the operating module 1 is further connected to the cover plate 31 to control the opening and closing of the cover plate 31 .

[0049] like Figure 4As shown, the lifting control module 2 and / or the arc-shaped housing 3 are provided with a searchlight 26, which can realize the positioning function: in the placement step, the position of the arc-shaped housing 3 can be guided and adjusted by observing the light through the sclera from the pupil. After accurate positioning, the cover plate 31 of the arc-shaped housing 3 is opened by the handle 10, and the reinforcement material and the adhesive plastic agent are pushed out and placed in the predetermined position, which solves the problem that general surgical instruments are difficult to operate on the sclera of the posterior pole, can reduce the exposure range of the surgical field, and can avoid damaging the important blood vessels and nerves in the posterior pole through visual operation, thereby reducing surgical injuries.

[0050] Among them, the adhesive plasticizer is photocurable, and the lifting control module 2 and / or the arc-shaped shell 3 are provided with a photocuring light source 25, which can configure the frequency and intensity of the light according to the properties of the adhesive plasticizer. In the photocuring step, the adhesive plasticizer can be evenly illuminated to achieve a good curing effect.

[0051] The adhesive plasticizer is a tissue glue of hydrogel or collagen component, and its mechanical strength, pore size, adhesion strength and degradation rate are controllable. It is preferably an elastin-like polypeptide modified with a methacrylic acid group or a polyethylene glycol diacrylate gel; the elastin-like polypeptide hydrogel modified with a methacrylic acid group is prepared by covalently modifying the lysine site of the elastin-like polypeptide with a methacrylic acid group, has photocrosslinking ability, and a controllable curing process. The mechanical strength can be regulated by the degree of modification of the methacrylic acid group and the concentration of the hydrogel, which can provide a microenvironment suitable for cell survival and is safe and non-toxic. Previous studies have verified that the elastin-like polypeptide hydrogel modified with a methacrylic acid group has good adhesion strength with human tissues close to the sclera structure such as the skin. In vivo experiments have shown that the hydrogel causes a weak peripheral inflammatory response, can exist stably for a long time, and has a low degradation rate.

[0052] The reinforcement material 4 is a biocompatible polymer film, artificial synthetic collagen, etc. The shape of the reinforcement material includes but is not limited to a rectangle, a shuttle, etc. It is preferably a polylactic acid electrospun film; the polylactic acid electrospun film has suitable elasticity and mechanical strength to resist the force of posterior scleral expansion. Its microstructure has been verified to be suitable for fibroblasts to migrate, proliferate and produce new collagen. The electrospinning process realizes a layered structure of the film, the pore size close to the sclera layer is the largest, the pore size away from the sclera layer is reduced, the density is increased, and the function of the film inducing cell migration and the mechanical strength are balanced. Based on the electrospinning process, a new generation of electrostatic direct writing process is adopted to achieve directional distribution of film fibers, induce directional distribution of newly generated collagen, and improve the biological reinforcement effect of the sclera. Preferably, the reinforcing material 4 is a thin film made by electrospinning, electrostatic direct writing technology and other processes, and the material thickness, mechanical strength, pore size and degradation rate and other characteristics are controllable. The material is a layered asymmetric structure, and each layer has different pore sizes and mechanical strengths; preferably, the scleral bonding surface of the reinforcing material 4 is rough to facilitate adhesion and cell proliferation, and the other side of the reinforcing material 4 is a smooth surface that inhibits adhesion of surrounding tissues, which can effectively inhibit adhesion of surrounding tissues. Each layer has different pore sizes and mechanical strengths.

[0053] Among them, the adhesive plasticizer and reinforcement material are suitable for carrying growth factors that induce tissue regeneration, such as microspheres of anti-inflammatory factors and other substances, and the above-mentioned anti-inflammatory factors can achieve a sustained release effect, promote tissue regeneration and inhibit inflammation.

[0054] Application Example 1:

[0055] like Figure 7 As shown, the ophthalmic surgical device for sclera of the present invention is used to reinforce the posterior sclera of patients with high myopia whose eye axis continues to grow. The reinforcement material 4 is a polylactic acid electrospinning film, and the adhesive plasticizer is an elastin-like polypeptide hydrogel modified with a methacrylic acid group. Before the operation, the curvature and length of the arc shell of the device are customized according to the three-dimensional reconstruction of the nuclear magnetic resonance of the operated eye, and the range of the deformation area of ​​the lifting control module liner is controlled. The center of the deformation area is the posterior pole of the eyeball.

[0056] The polylactic acid electrospun film and the elastin-like polypeptide hydrogel modified with methacrylic acid groups are sequentially loaded into the arc-shaped housing 3. The conjunctiva and fascial capsule are cut along the range of 2 o'clock to 6 o'clock of the corneal margin, and the lateral rectus muscle 53, the inferior rectus muscle and the inferior oblique muscle are separated. The ophthalmic surgical device for the sclera of the present invention is placed between the inferior rectus muscle and the inferior oblique muscle belly and the sclera along the curvature of the eyeball. The searchlight 26 of the lining plate 22 is turned on, and the light passing through the sclera is observed through the pupil using a surgical microscope to determine that the device covers the macular area and maintains a safe distance from the optic nerve 52. The arc-shaped housing cover plate 3 is opened by the handle 10, and the lifting mechanism 21 of the contraction lifting control module 2 is controlled to lift the reinforcement material 4 and the adhesive plasticizer loaded on the lining plate 22 to attach them to the surface of the sclera, and at the same time, the lining plate 22 is deformed to make the reinforcement material 4 in the corresponding area bulge centripetally. Turn on the light curing light source 25 to perform light curing, complete the shaping and make the polylactic acid electrospun film adhere to the scleral surface through the elastin-like polypeptide hydrogel modified with methacrylic acid groups. Retract the lifting control module 2 through the handle 10 and withdraw the ophthalmic surgical device along the curvature of the eyeball.

[0057] Application Example 2:

[0058] The ophthalmic surgical device for sclera described in the present invention is used to reinforce the posterior scleral staphyloma of pathological myopia patients with posterior scleral staphyloma with the assistance of intraoperative optical tomography (OCT). The reinforcement material is a polylactic acid electrospun film, and the adhesive plasticizer is an elastin-like polypeptide hydrogel modified with a methacrylate group.

[0059] Before the operation, the operated eye was reconstructed in three dimensions through magnetic resonance imaging, with emphasis on the location of the posterior scleral staphyloma, to determine the direction of the surgical approach, and to design the length, width, and size of the reinforced pad pressure range of the polylactic acid electrospinning film. The reinforced pad pressure range should be at least the range of the staphyloma base. The curvature and length of the curved shell of the device were customized based on the above information, and the position and range of the deformation area of ​​the lifting control module liner were determined.

[0060] The polylactic acid electrospun film and the elastin-like polypeptide hydrogel modified with methacrylic acid groups are sequentially loaded into the arc-shaped housing. During the operation, OCT confirms the location of the staphyloma again, opens the conjunctiva and fascial sac at the predetermined position, separates the extraocular muscles, and inserts the ophthalmic surgical device for the sclera of the present invention. Turn on the liner searchlight, and use a surgical microscope to observe the light through the sclera through the pupil to move the device to the location of the staphyloma. Open the arc-shaped housing cover by the handle, control the lifting mechanism of the contraction and lifting control module, lift the reinforcement material and adhesive plasticizer loaded on the liner and attach them to the surface of the sclera, and at the same time, the liner deforms to make the reinforcement material in the corresponding area bulge concentrically. Fine-tune the position of the device under the guidance of OCT during the operation to confirm that the top pressure position is strengthened to compress the staphyloma. Turn on the light curing light source, perform light curing, complete the shaping, and make the polylactic acid electrospun film adhere to the surface of the sclera through the elastin-like polypeptide hydrogel modified with methacrylic acid groups. Retract the lifting control module by the handle, and withdraw the ophthalmic surgical device along the curvature of the eyeball.

[0061] The above content is a further detailed description of the present invention in combination with specific / preferred embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. For ordinary technicians in the technical field to which the present invention belongs, without departing from the concept of the present invention, it can also make several substitutions or modifications to these described embodiments, and these substitutions or modifications should be regarded as belonging to the protection scope of the present invention. In the description of this specification, the description of the reference terms "an embodiment", "some embodiments", "preferred embodiments", "examples", "specific examples", or "some examples" means that the specific features, structures, materials or characteristics described in combination with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily target the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In the absence of mutual contradiction, 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. Although the embodiments of the present invention and their advantages have been described in detail, it should be understood that various changes, substitutions and modifications can be made herein without departing from the scope of protection of the patent application.

Claims

1. An ophthalmic surgical device for sclera, characterized in that: The invention comprises a manipulation module, a lifting control module and an arc-shaped shell, wherein the arc-shaped shell has a curvature and a length adapted to the shape of the eyeball, an open cavity is arranged on one side of the arc-shaped shell for matching the sclera of the eyeball, the lifting control module is installed in the open cavity, the lifting control module is used to load and apply reinforcing materials and adhesive plasticizers to the sclera of the eyeball, the manipulation module is connected to the lifting control module, and is used to manipulate the lifting control module to lift out of the open cavity to apply the reinforcing materials and adhesive plasticizers to the sclera of the eyeball, and manipulate the lifting control module to return to the open cavity after the application is completed; the lifting control module comprises a retractable and deformable lifting mechanism and an elastic lining plate The lifting mechanism is connected to the operating module, the lining plate is arranged on the lifting mechanism, the adhesive plasticizer and the reinforcing material are loaded on the lining plate, the lining plate is in an arc-shaped flat state in the initial state, the lifting mechanism produces telescopic changes under the control of the operating module, the height of the lifting mechanism is lifted when it contracts, so that the lining plate produces a bending deformation with a centripetal bulge, and the height of the lifting mechanism is reduced when it extends, and the lining plate returns to flatness; the lifting mechanism is connected to the lining plate through a plurality of fixed fulcrums, and the plurality of fixed fulcrums limit the deformation area of ​​the centripetal bulge of the lining plate; the lifting mechanism includes a chain structure formed by a plurality of deformable polygonal repeating elements connected in series.

2. The ophthalmic surgical device according to claim 1, characterized in that: The multiple fixed fulcrums include multiple fixing parts, multiple adjustment grooves arranged on the lining plate and multiple connecting holes arranged on the lifting mechanism. Each fixing part passes through the corresponding adjustment groove and connecting hole to fix the lifting mechanism and the lining plate. The adjustment groove is used to pre-adjust the position of the fixing part to achieve the adjustment of the position and size of the deformation area of ​​the lining plate.

3. The ophthalmic surgical device according to claim 2, characterized in that: The lifting mechanism and the lining plate are further provided with a sliding pair at a position outside the deformation area, and are connected in a slidable manner through the sliding pair, and the sliding pair is arranged along the direction of the telescopic deformation of the lifting mechanism.

4. The ophthalmic surgical device according to claim 1, wherein: The lifting mechanism and / or the lining plate are made of polylactic acid.

5. The ophthalmic surgical device according to claim 4, characterized in that: The surface of the lining plate has anti-sticking texture.

6. The ophthalmic surgical device according to claim 4, characterized in that: The surface of the liner is provided with a polyethylene layer and coated with organic silicone oil as an anti-adhesion release layer.

7. The ophthalmic surgical device according to any one of claims 1 to 6, characterized in that: It also includes a cover plate which is opened and closed on the open cavity, and the operating module is also connected to the cover plate to control the opening and closing of the cover plate.

8. The ophthalmic surgical device according to any one of claims 1 to 6, characterized in that: The operating module includes a handle, a lifting mechanism retractable handle, a Bowden cable, a Bowden tube and a reset spring. The arc-shaped shell is connected to the handle, and the lifting mechanism retractable handle is installed on the handle. One end of the Bowden cable is connected to the lifting mechanism retractable handle, and the other end of the Bowden cable is connected to the distal end of the lifting mechanism. One end of the Bowden tube is against the proximal end of the lifting mechanism, and the other end of the Bowden tube is fixed to the handle. A reserved hole is provided on the handle, and the reset spring is placed in the reserved hole. The lifting mechanism retractable handle is limited in the reserved hole and is located on the reset spring. A pulley is provided in the reserved hole, and the Bowden cable is connected to the lifting mechanism retractable handle through the pulley.

9. The ophthalmic surgical device according to any one of claims 1 to 6, characterized in that: The lifting control module and / or the arc-shaped housing are provided with a searchlight.

10. The ophthalmic surgical device according to any one of claims 1 to 6, characterized in that: The adhesive plasticizer is photocurable, and the lifting control module and / or the arc-shaped housing is provided with a photocuring light source.

11. The ophthalmic surgical device according to claim 10, wherein: The adhesive plasticizer is a hydrogel or collagen-based tissue glue; the reinforcing material is a biocompatible high molecular polymer film.

12. The ophthalmic surgical device according to claim 11, wherein: The adhesive plasticizer is an elastin-like polypeptide modified with a methacrylic acid group or a polyethylene glycol diacrylate gel.

13. The ophthalmic surgical device according to claim 11, wherein: The reinforcement material is a polylactic acid electrostatic spinning film.

14. The ophthalmic surgical device according to claim 11, wherein: The reinforcing material is a layered asymmetric structure, and each layer has different pore sizes and mechanical strengths.

15. The ophthalmic surgical device according to claim 11, wherein: The sclera-joining surface of the reinforcement material is rough to facilitate adhesion and cell proliferation, and the other side of the reinforcement material is a smooth surface to inhibit adhesion of surrounding tissues.

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