Intraocular lens zonular suspension self-locking fixation device and fixation method

Abstract

The application discloses an artificial lens sclera suspension self-locking fixing device and a fixing method, and relates to the medical treatment technical field. The artificial lens sclera suspension self-locking fixing device comprises an implantable self-locking fixing component, the implantable self-locking fixing component comprises an anchor plug main body, the anchor plug main body comprises a leading-in part at the front end, a connecting part at the middle part and an asymmetric double-clamping petal structure at the rear end, the connecting part is connected to the leading-in part, the asymmetric double-clamping petal structure is connected to the connecting part, the asymmetric double-clamping petal structure is used for forming a tissue anti-back-off cooperation with sclera tissue through elastic rebound after being implanted between sclera layers, and the asymmetric double-clamping petal structure comprises a first clamping petal and a second clamping petal. The artificial lens sclera suspension self-locking fixing device has the beneficial effects that the implantable self-locking fixing component is used to replace threading, knotting and burying thread and other steps to suspend the lens, the repeated puncture of the sclera is reduced, the operation steps are simplified, the learning difficulty is reduced, the suture exposure risk is reduced, the tissue damage is reduced, the intraoperative tension adjustment is facilitated, and the artificial lens is beneficial to centering.

Description

Technical Field

[0001] This invention relates to the field of intraocular lens fixation technology, specifically to an intraocular lens scleral suspension self-locking fixation device and fixation method. Background Technology

[0002] For patients with non-capsular support eyes, such as those with trauma, lens dislocation, or those who have undergone complex cataract surgery, artificial lens suspension and fixation techniques are often required to restore visual function.

[0003] Currently commonly used methods include: Scleral fixation with polypropylene sutures; Z-shaped suture fixation; Flange fixing technology; Interlaminar fixation technique for sclera.

[0004] The above technologies all have defects to varying degrees: The sclera underwent numerous repeated punctures; The surgical procedure is complex; The learning curve is steep. The surgery takes a long time; Risk of suture exposure; Crystal centering adjustment is difficult; Long-term stability is affected by suture wear.

[0005] Therefore, there is a need for a self-locking device and method for suspending and fixing artificial lenses and sclera that requires no knotting or flange forming and can achieve rapid fixation.

[0006] Therefore, in view of the above-mentioned technical problems, it is necessary to provide a self-locking fixation device and fixation method for scleral suspension of artificial lenses. Summary of the Invention

[0007] This invention aims to provide a self-locking fixation solution for implantable scleral ligation. By implanting a self-locking fixation component into the scleral layer, it achieves fixation, tension adjustment, and anti-slip locking of the ligation, reducing the steps involved in traditional scleral ligation procedures such as suture knotting, embedding, and flange fabrication, thereby improving the efficiency and stability of intraocular lens fixation. This invention uses an implantable self-locking fixation component as the ligation fixation carrier. The ligation and the implantable fixation component are placed together in the scleral layer. Tissue restraint is formed between the fixation component and the scleral tissue, and a self-locking structure is formed within the fixation component, achieving tension adjustment and knot-free fixation of the ligation. The self-locking structure of the ligation can be implemented using an elastic clamping structure, a suture pressing structure, a guide locking structure, or other structures capable of restricting ligation slippage.

[0008] In view of the shortcomings of the prior art, the purpose of this invention is to provide an intraocular lens scleral suspension self-locking fixation device and fixation method to solve the problems mentioned in the background art.

[0009] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: This invention provides a scleral suspension self-locking fixation device for artificial lenses, comprising an implantable self-locking fixation component. The implantable self-locking fixation component includes an anchor plug body, which includes a front guide portion, a middle connecting portion, and a rear asymmetric double-clamping flap structure. The connecting portion is connected to the guide portion, and the asymmetric double-clamping flap structure is connected to the connecting portion. The asymmetric double-clamping flap structure is used to form a tissue-locking fit with the scleral tissue through elastic rebound after implantation into the scleral layer. The asymmetric double clamping flap structure includes a first clamping flap and a second clamping flap. A suspension wire compression space is formed between the first clamping flap and the second clamping flap. A suspension wire can be provided in the suspension wire compression space. The first clamping flap and the second clamping flap are used to clamp the suspension wire after implantation, forming a wire anti-retraction fit. The asymmetric double-clamping flap structure is connected to an auxiliary traction structure. The auxiliary traction structure includes a first auxiliary wire fixedly connected to the first clamping flap, and a second auxiliary wire fixedly connected to the second clamping flap.

[0010] In one or more embodiments of the present invention, the first clamping petal and the second clamping petal are respectively structures with a raised middle section and narrowed ends, and the first clamping petal and the second clamping petal are in a slightly open posture in their natural state.

[0011] In one or more embodiments of the present invention, the length of the first clamping flap is greater than the length of the second clamping flap.

[0012] In one or more embodiments of the present invention, the bottom end face of the inlet portion is connected to an inlet head, the inlet head has a blunt conical structure, and the front end surface of the inlet head and each guide opening on the outer wall of the inlet portion are provided with rounded chamfers.

[0013] In one or more embodiments of the present invention, an inwardly recessed suspension line positioning area is provided on the outer wall of the connecting part, and a suspension line can be provided in the suspension line positioning area. The bottom width of the suspension line positioning area is slightly larger than the diameter of the suspension line, and the suspension line positioning area is a straight groove or a curved groove.

[0014] In one or more embodiments of the present invention, the inner surface of the suspension line positioning area is provided with a friction-enhancing structure, wherein the friction-enhancing structure is a corrugated structure.

[0015] In one or more embodiments of the present invention, a guide slider is provided at one end of the connecting part, a pressure line area is provided inside the anchor plug body, a pressure line angle is formed between the bottom of the pressure line area and the connecting part, and a guide wire inclined towards the inside of the anchor plug body is connected to the upper end face of the guide slider, the guide wire passing through the first clamping petal.

[0016] In one or more embodiments of the present invention, the anchor plug body is a non-cylindrical structure, and the outer contour of the anchor plug body forms an attitude constraint with the inner wall of the scleral interlaminar tunnel, restricting the anchor plug body from rotating around its axis within the scleral interlaminar tunnel.

[0017] The present invention also provides a method for self-locking fixation of scleral suspension with an artificial lens, comprising the following steps: S1. Creating a scleral tunnel: In the predetermined scleral fixation area, a tunnel is made in the scleral layer using a tunneling knife or puncture needle. The depth and length of the tunnel are adapted to the size of the anchor plug body. S2, Pre-installed suspension line: One end of the artificial lens suspension wire is passed through the interscleral tunnel, with an appropriate length reserved for subsequent fixation; S3. Insert the suspension line into the anchor plug body: The suspension line is directly inserted into the suspension line compression space between the first clamping flap and the second clamping flap; Alternatively, the suspension line can be embedded in the suspension line positioning groove on the outer wall of the connector; S4. Implanted anchor plug body: Using the auxiliary traction structure, namely pulling the first auxiliary wire and the second auxiliary wire, the anchor plug body is slowly advanced along the interscleral tunnel; During implantation, the blunt conical tip of the implantation head and the rounded chamfers at each guide port reduce resistance and prevent damage to the suspension wire; The first and second clamping flaps of the asymmetric double clamping flap structure are deformed sequentially due to their different lengths (the first clamping flap deforms first, and the second clamping flap deforms later). The deformation area is misaligned along the axial direction to avoid stress concentration and make implantation smoother. S5. Elastic rebound and self-locking fixation: Once the anchor plug body is fully inserted into the predetermined position, the first clamping flap and the second clamping flap elastically rebound and return to a slightly open state. After rebounding, the double flaps and scleral tissue form a mechanical anti-retraction structure, achieving tissue anti-retraction and preventing the anchor plug from retracting and coming out. At the same time, the suspension line is clamped in the suspension line compression space, suspension line positioning area or pressure area to achieve line anti-regression; The organization's backstop and the line's backstop together form a double fixation; S6. Adjust the position and suspension tension of the intraocular lens to ensure that the intraocular lens is centered, the suspension tension is appropriate, and the lens is securely fixed. If adjustments are needed, the auxiliary wire can be used to remove the anchor plug, readjust, and then implant the lens again. After confirming that everything is correct, cut the auxiliary wire and traction wire to retract the remaining end into the tunnel between the scleral layers. S7. After confirming that everything is correct, suture the conjunctiva as needed to end the surgery.

[0018] In one or more embodiments of the present invention, step S3, after the suspension wire is embedded in the suspension wire positioning area groove on the outer wall of the connecting part, further includes: driving the guide slider to move upward by pulling the guide wire, pressing the suspension wire to bend and deform at the pressure angle, thereby achieving bending locking.

[0019] In this invention, the implantable self-locking fixation component is not limited to the specific structures described below. Its core lies in utilizing a fixation component implanted between the scleral layers to achieve adjustable, self-locking, and anti-regression fixation of the suspension suture. The following embodiments are merely preferred embodiments of this invention and are not intended to limit the scope of protection of this invention. The self-locking fixation component includes an implantation part and a suture-locking part. The implantation part is responsible for fixing to the sclera, and the suture-locking part is responsible for fixing the suture. These two functions constitute the core technical concept of this invention. The suture-locking part can be implemented using a double-clamping flap structure, a guide groove structure, a suture-pressing slider structure, etc. Those skilled in the art can also make equivalent substitutions or modifications based on the above structures, all of which fall within the scope of protection of this invention without departing from its technical concept.

[0020] The beneficial effects of this invention are as follows: Using implantable self-locking fixation components to suspend the lens instead of sutures and knots reduces repeated scleral punctures; simplifies surgical procedures; reduces learning difficulty; reduces the risk of suture exposure; reduces tissue damage; facilitates intraoperative tension adjustment; and helps to center the artificial lens.

[0021] The anchor plug has a non-cylindrical structure, which forms an attitude constraint with the tunnel between the sclera and the sclera, effectively reducing the rotation of the anchor plug in the tunnel and improving the fixed orientation stability.

[0022] By using the elastic rebound of the asymmetric double-clamping flap and the scleral tissue to form tissue fixation, while simultaneously clamping the suspension suture to form line fixation, the tissue fixation and line fixation work together to form a dual fixation mechanism, which significantly improves the long-term stability of fixation.

[0023] All guide openings are equipped with rounded chamfers and continuous rounded transitions to avoid cutting damage to the suspension line and ensure the structural integrity and long-term strength of the suspension line.

[0024] The suspension line allows for multiple adjustments. The anchor plug can be removed using an auxiliary wire, and the tension and position can be readjusted before re-implantation. The operation is reversible and error-tolerant, reducing surgical risks.

[0025] The self-locking fixing method of the present invention is not limited to the double clamping petal structure; the same technical concept can be achieved by positioning groove or slider pressure line structure, etc., and the scope of protection is not limited to the specific embodiment. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the first usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 1 ; Figure 2 This is a schematic diagram of the first usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 2 ; Figure 3 This is a schematic diagram of the second usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 1 ; Figure 4 This is a schematic diagram of the second usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 2 ; Figure 5 This is a schematic diagram of the third usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 1 ; Figure 6 This is a schematic diagram of the third usage state of a self-locking fixation device for scleral suspension of an artificial lens according to an embodiment of the present invention. Figure 2 ; Figure 7 This is a schematic diagram illustrating the implantation and self-locking process of an artificial lens scleral suspension self-locking fixation device according to an embodiment of the present invention; Figure 8 This is a flowchart of a method for self-locking fixation of scleral suspension with an artificial lens according to an embodiment of the present invention.

[0028] Explanation of reference numerals in the attached figures: 11. Anchor plug body; 21. Inlet section; 22. Inlet head; 31. Asymmetric double clamping flap structure; 32. First clamping flap; 33. Second clamping flap; 34. Auxiliary traction structure; 35. First auxiliary wire; 36. Second auxiliary wire; 41. Connecting part; 51. Suspension line compression space; 52. Suspension line; 61. Suspension line positioning area; 71. Guide slider; 72. Pressure line area; 73. Pressure line angle; 74. Guide wire. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] Example 1: like Figures 1 to 8 As shown in the figure, an embodiment of the present invention discloses a self-locking fixation device and method for scleral suspension of an intraocular lens. The fixation device includes an implantable self-locking fixation component, which includes an anchor body 11. The anchor body 11 is made of medical-grade polymer material or biocompatible metal material, possessing good biocompatibility and appropriate elastic deformation capability. The anchor body 11 has a non-cylindrical structure, and its outer contour forms a posture constraint with the inner wall of the scleral interlaminar tunnel, restricting the anchor body 11 from rotating around its axis within the scleral interlaminar tunnel, thereby ensuring that the fixation orientation of the suspension line 52 remains stable, which is beneficial for the long-term centering of the intraocular lens.

[0031] The anchor plug body 11 includes a front-end guide portion 21, a middle connecting portion 41, and a rear-end asymmetric double-clamping flap structure 31. The connecting portion 41 is connected to the guide portion 21, and the asymmetric double-clamping flap structure 31 is connected to the connecting portion 41. A guide head 22 is connected to the bottom end face of the guide portion 21. The guide head 22 has a blunt conical structure. The front surface of the guide head 22 is smooth and rounded, without sharp edges, to reduce the implantation resistance when the anchor plug body 11 is implanted into the scleral interlaminar tunnel, while also reducing cutting and damage to the scleral tissue. The conical structure of the guide head 22 also facilitates the surgeon's accurate insertion of the anchor plug body 11 into the pre-fabricated scleral interlaminar tunnel during the operation. The front surface of the guide head 22 and each guide opening on the outer wall of the guide portion 21 are provided with rounded chamfers. All locations where the suspension wire 52 passes through use continuous rounded transitions to avoid cutting or abrasion damage to the suspension wire 52 during implantation, ensuring the structural integrity and long-term strength of the suspension wire 52.

[0032] The asymmetric double-clamping flap structure 31 includes a first clamping flap 32 and a second clamping flap 33. The first clamping flap 32 and the second clamping flap 33 are respectively divided axially from the tail end of the anchor plug body 11, forming a suspension wire compression space 51 between them. The suspension wire 52 can be placed into the suspension wire compression space 51. The first clamping flap 32 and the second clamping flap 33 are respectively structures that are raised in the middle and narrowed at both ends, that is, the radial dimension of the middle region is larger than the radial dimension of the two end regions. In the natural state, it is slightly open and will not open too wide like a tree branch, which facilitates smooth implantation into the scleral interlaminar tunnel.

[0033] The first clamping flap 32 and the second clamping flap 33 are made of elastic material, capable of elastic deformation under external pressure and returning to a slightly open state after the external force is released. Because the first clamping flap 32 and the second clamping flap 33 have different lengths (the first clamping flap 32 is longer than the second clamping flap 33), during the advancement of the anchor plug body 11 along the scleral interlaminar tunnel, the first clamping flap 32 is first subjected to pressure from the scleral tissue and undergoes elastic deformation, followed by the second clamping flap 33. The deformation areas of the two flaps are staggered along the axial direction, avoiding the stress concentration problem of the symmetrical double-flap structure at the same cross-section, thereby effectively reducing implantation resistance and improving the smoothness of the implantation process. After the anchor plug body 11 is implanted in place, the first clamping flap 32 and the second clamping flap 33 elastically rebound, forming a mechanical anti-retraction structure (tissue anti-retraction) with the scleral tissue, preventing the anchor plug body 11 from dislodging from the scleral interlaminar tunnel. Simultaneously, the rebounding first clamping flap 32 and second clamping flap 33 clamp the suspension wire 52 located within the suspension wire compression space 51, forming a wire anti-retraction mechanism. The tissue anti-retraction and the wire anti-retraction work together to form a dual fixation mechanism, significantly improving the long-term stability of the fixation.

[0034] An auxiliary traction structure 34 is connected to the asymmetric double-clamping flap structure 31. The auxiliary traction structure 34 includes a first auxiliary wire 35 fixedly connected to the first clamping flap 32 and a second auxiliary wire 36 fixedly connected to the second clamping flap 33. The first auxiliary wire 35 and the second auxiliary wire 36 extend outward from the ends of the first clamping flap 32 and the second clamping flap 33, respectively. The first auxiliary wire 35 and the second auxiliary wire 36 are made of elastic polymer material and have appropriate flexibility and elasticity. During the operation, the surgeon can adjust the position and implantation direction of the anchor body 11 by pulling the first auxiliary wire 35 and the second auxiliary wire 36, which facilitates intraoperative tension adjustment and intraocular lens centering. After the anchor body 11 is implanted, the first auxiliary wire 35 and the second auxiliary wire 36 are cut at an appropriate position. The cut ends enter the scleral interlaminar tunnel due to the elastic recoil of the material, thereby reducing the risk of irritation to the ocular surface.

[0035] In this embodiment, a scleral interlaminar tunnel is first created in the predetermined scleral fixation area using a tunneling knife or puncture needle. The depth and length of the tunnel are adapted to the size of the anchor body 11. Then, one end of the intraocular lens suspension wire 52 is passed through the scleral interlaminar tunnel, with an appropriate length reserved for subsequent fixation. The suspension wire 52 is then directly placed into the suspension wire compression space 51 between the first clamping flap 32 and the second clamping flap 33. Subsequently, the auxiliary traction structure 34, i.e., pulling the first auxiliary wire 35 and the second auxiliary wire 36, is used to slowly advance the anchor body 11 along the scleral interlaminar tunnel. During implantation, the blunt conical tip of the guide head 22 and the rounded chamfers at each guide opening reduce resistance and avoid damage to the suspension wire 52. Due to their different lengths, the first clamping flap 32 and the second clamping flap 33 of the asymmetric double clamping flap structure 31 are deformed sequentially under pressure (the first clamping flap deforms first, and the second clamping flap deforms later). The deformation area is misaligned along the axial direction to avoid stress concentration and make implantation smoother. After the anchor plug body 11 is fully implanted in the predetermined position, the first clamping flap 32 and the second clamping flap 33 elastically rebound, returning to a slightly open state. The rebounded double flaps form a mechanical anti-retraction structure (tissue anti-retraction) with the scleral tissue, preventing the anchor plug from retracting and falling out. At the same time, the suspension wire 52 is clamped within the suspension wire compression space 51, achieving wire anti-retraction. Tissue anti-retraction and wire anti-retraction together form a double fixation. Check the suspension wire tension and the centering position of the intraocular lens. If the position is not satisfactory, the anchor plug body 11 can be withdrawn from the scleral interlaminar tunnel by pulling the first auxiliary wire 35 and / or the second auxiliary wire 36 in the opposite direction. The tension or position of the suspension wire 52 can be readjusted and then re-implanted. The suspension wire 52 can be repeatedly adjusted multiple times without causing significant damage to the clamping function of the asymmetric double clamping flap structure 31. Finally, check the suspension wire tension and the centering position of the intraocular lens, cut the auxiliary wires and traction wires, and retract their residual ends into the scleral interlaminar tunnel. After confirming that everything is correct, suture the conjunctiva as needed to complete the surgery.

[0036] Example 2: like Figures 1 to 8 As shown, the difference between this embodiment and Embodiment 1 lies in the placement position of the suspension line 52. In this embodiment, the suspension line 52 is placed within the suspension line positioning area 61.

[0037] A recessed suspension line positioning area 61 is provided on the outer wall of the connecting part 41. The suspension line positioning area 61 is a recessed groove structure extending axially along the connecting part 41. The bottom width of the groove of the suspension line positioning area 61 is slightly larger than the diameter of the suspension line 52, so that the suspension line 52 can be just accommodated in the groove and move freely in the groove; while the clamping gap of the suspension line compression space 51 is smaller than the diameter of the suspension line 52, ensuring that the clamping petals can effectively clamp the suspension line 52 after rebounding. The suspension line positioning area 61 is a straight groove or a curved groove structure. In this embodiment, the suspension line positioning area 61 adopts a straight groove structure. The opening of the straight groove faces both sides, and the bottom of the groove has a smooth arc transition. All guide openings through which the suspension line 52 passes are provided with arc chamfers, and a continuous arc transition is used to avoid damage to the suspension line 52. The straight groove forms a more sufficient enclosure and constraint for the suspension line 52, effectively preventing the suspension line 52 from coming out of the groove.

[0038] The inner surface of the suspension line positioning area 61 is provided with a friction-enhancing structure. This friction-enhancing structure is a corrugated structure, with the crests and troughs of the corrugations alternating along the extension direction of the suspension line positioning area 61. The corrugated structure increases the contact area and friction coefficient between the suspension line 52 and the inner wall of the suspension line positioning area 61, making it less prone to slippage of the suspension line 52 during implantation. Simultaneously, the corrugated structure also provides a certain degree of elastic buffering, absorbing some energy when the anchor plug body 11 is subjected to external impact, thus improving the long-term stability of the fixation.

[0039] In this embodiment, firstly, a scleral interlayer tunnel is created in the predetermined scleral fixation area using a tunneling knife or puncture needle. The depth and length of the tunnel are adapted to the size of the anchor body 11. Then, one end of the intraocular lens suspension wire 52 is passed through the scleral interlayer tunnel, with an appropriate length reserved for subsequent fixation. Next, the suspension wire 52 is pre-placed in the straight groove of the suspension wire positioning area 61 and embedded into the suspension wire positioning area 61. Subsequently, the anchor body 11 is advanced along the scleral interlayer tunnel using the auxiliary traction structure 34. During the advancement process, the suspension wire 52 is constrained within the suspension wire positioning area 61 and will not undergo lateral displacement. The first clamping flap 32 and the second clamping flap 33 of the asymmetric double clamping flap structure 31 deform under the pressure of scleral tissue during advancement. After implantation, they elastically rebound, forming a mechanical anti-retraction structure (tissue anti-retraction) with the scleral tissue, while simultaneously clamping the suspension wire 52 to form a linear anti-retraction, achieving double fixation. The suspension suture positioning area 61 also facilitates intraoperative adjustment of the tension of the suspension suture 52. The surgeon can adjust the tension of the suspension suture 52 by pulling its free end during or after the implantation of the anchor plug body 11, thereby achieving centering adjustment of the intraocular lens. After adjustment, the suspension suture 52 is firmly fixed within the suspension suture positioning area 61, maintaining long-term stable suspension of the intraocular lens. If the position is unsatisfactory, the anchor plug can be removed by pulling the auxiliary wire in the opposite direction, readjusted, and re-implanted. The suspension suture 52 allows for multiple adjustments without causing significant damage to the clamping structure. Finally, the suspension suture tension and the centering position of the intraocular lens are checked. After confirmation, the first auxiliary wire 35 and the second auxiliary wire 36 are cut at appropriate positions. After cutting, the remaining ends automatically retract into the scleral tunnel due to elastic recoil. After confirmation, the conjunctiva is sutured as needed to complete the surgery.

[0040] The other structures and working principles of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0041] Example 3: like Figures 1 to 8 As shown, the difference between this embodiment and embodiments one and two is that a guide slider 71 is provided at one end of the connecting part 41, and a pressure area 72 is provided inside the anchor plug body 11. A pressure angle 73 is formed between the bottom of the pressure area 72 and the connecting part 41. A guide wire 74 inclined towards the inside of the anchor plug body 11 is connected to the upper end face of the guide slider 71. The guide wire 74 passes through the first clamping petal 32.

[0042] One end of the connecting part 41 is axially segmented to form a guide slider 71. The guide wire 74 facilitates the upward movement of the guide slider 71. The anchor plug body 11 has a pressure area 72 above the guide slider 71 to accommodate the guide slider 71 and the suspension line 52. A pressure angle 73 is formed between the bottom of the pressure area 72 and the connecting part 41. The pressure angle 73 is an acute angle structure used to bend or fold the suspension line 52 when the guide slider 71 moves upward.

[0043] In this embodiment, the suspension line positioning area 61 is a straight groove structure. The straight groove extends axially along the connecting part 41, and the bottom width of the groove is slightly larger than the diameter of the suspension line 52. All guide openings are provided with rounded chamfers, using continuous rounded transitions. The suspension line 52 can freely travel along the straight groove. The upper end face of the guide slider 71 is connected to a guide wire 74 that is inclined towards the inside of the anchor plug body 11. One end of the guide wire 74 is fixed to the upper end face of the guide slider 71, and the other end passes through the first clamping flap 32 and extends to the outside of the anchor plug body 11. The guide wire 74 is made of medical material with appropriate rigidity and is used by the surgeon to manipulate during the operation to drive the guide slider 71 to move relative to the main body of the connecting part 41.

[0044] In this embodiment, firstly, a scleral interlaminar tunnel is created in the predetermined scleral fixation area using a tunneling knife or puncture needle. The depth and length of the tunnel are adapted to the size of the anchor body 11. Then, one end of the intraocular lens suspension wire 52 is passed through the scleral interlaminar tunnel, leaving an appropriate length for subsequent fixation. The suspension wire 52 is then placed in the straight groove of the suspension wire positioning area 61. Subsequently, using the auxiliary traction structure 34, namely pulling the first auxiliary wire 35 and the second auxiliary wire 36, the anchor body 11 is slowly advanced along the scleral interlaminar tunnel. During implantation, the guide wire 74 can be used as a temporary traction wire to help the surgeon control the implantation direction of the anchor body 11. After the anchor body 11 is implanted in place, the surgeon drives the guide slider 71 to move upward relative to the main body of the connecting part 41 by pulling or pushing the guide wire 74. When the guide slider 71 moves upward, it is fixed in the pressure zone 72 under the pressure of the interscleral tunnel, thereby pressing the suspension line 52 located in the pressure zone 72, causing the suspension line 52 to bend and deform at the pressure angle 73. After the suspension line 52 is bent, its path changes from a straight line to a bent state, thereby increasing the path length and frictional resistance of the suspension line 52 in the anchor plug body 11, further improving the positioning stability of the suspension line 52. At the same time, the bending deformation of the suspension line 52 also forms a mechanical locking fit between it and the pressure angle 73, making it difficult to slip even under external force. In this embodiment, the suspension line 52 is located in the straight groove of the suspension line positioning area 61, and is bent by the cooperation of the guide slider 71 and the pressure angle 73, achieving a triple fixing effect: first, the lateral constraint of the suspension line positioning area 61 on the suspension line 52; second, the friction fixing provided by the friction-increasing structure on the inner surface of the suspension line positioning area 61; and third, the bending locking of the suspension line 52 at the pressure angle 73. The triple fixation effect works synergistically to significantly improve the stability of the suspension wire 52, effectively preventing slippage or loosening during long-term use. If the position is unsatisfactory, the anchor plug can be removed by pulling the auxiliary wire in the opposite direction, readjusted, and re-implanted; the suspension wire 52 allows for multiple adjustments without causing significant damage to the clamping structure. After implantation, the guide wire 74 remains inside the anchor plug body 11 and is not removed; its end can be cut along with the first auxiliary wire 35 and the second auxiliary wire 36. Finally, the tension of the suspension wire and the centering position of the intraocular lens are checked. After confirmation, the first auxiliary wire 35, the second auxiliary wire 36, and the guide wire 74 are cut at appropriate positions. After cutting, the remaining ends automatically retract into the scleral tunnel due to elastic recoil. After confirmation, the conjunctiva is sutured as needed to complete the surgery.

[0045] The other structures and working principles of this embodiment are the same as those of Embodiment 1 and Embodiment 2, and will not be repeated here.

[0046] Example 4: To verify the structural feasibility and implantation fixation principle of the artificial lens scleral suspension self-locking fixation device of the present invention, a principle verification experiment was conducted using an isolated pig eye.

[0047] In the experiment, a scleral interlaminar tunnel adapted to the size of the anchor plug body was fabricated in the predetermined scleral fixation area of ​​an isolated pig eye. Using CR9003 intraocular lens loop material, an appropriate length was cut and processed to form a principle verification sample corresponding to the anchor plug body structure of this invention, used to simulate the implantation and self-locking fixation process of the anchor plug body. A suspension wire loop was formed and placed in the suspension wire compression space (or suspension wire positioning area) of the anchor plug body. The anchor plug body was then implanted into the scleral interlaminar tunnel, and the suspension wire tension was adjusted as needed to complete the suspension wire fixation.

[0048] During the experiment, the prototype successfully entered the scleral interlaminar tunnel. During implantation, the clamping structure underwent elastic deformation under the constraint of the scleral tissue. After implantation, the clamping structure returned to its natural state, mechanically clamping the suspension line and fixing it. The tension of the suspension line could be adjusted as needed during the experiment, and fixation was completed once the predetermined tension was reached.

[0049] During the principle verification process, no obvious structural failure was observed in the implantation sample, and the suspension wire remained fixed, verifying the feasibility of the implantable self-locking fixation principle proposed in this invention.

[0050] It should be noted that the prototype formed by processing CR9003 intraocular lens haptic material in this embodiment is only used to verify the structural principle, implantation method, and self-locking fixation process of the technical solution of this invention, and does not constitute a limitation on the materials of the final product of this invention. The final product of this invention can be manufactured using polyetheretherketone (PEEK), polypropylene (PP), polymethyl methacrylate (PMMA), nickel-titanium alloy, or other medical materials with good biocompatibility, depending on clinical needs. This embodiment mainly verifies the feasibility of the structural solution of this invention. Regarding the long-term tissue compatibility and long-term fixation effect of different materials, further verification can be conducted through animal experiments or clinical applications, depending on the specific materials used.

[0051] This embodiment demonstrates that the present invention can fix the artificial lens suspension wire through an implantable self-locking fixation structure, without the need for traditional fixation methods such as suture knotting, embedding, or flange forming, thus verifying that the technical solution of the present invention can achieve the expected technical purpose.

[0052] The implantation and self-locking process of the device of the present invention is as follows: A: Natural state (before implantation); B: Implantation process (double valve compression closure); B1: Local magnification (double lobes under pressure); C: Fixation complete (double-lobed springback self-locking); C1: Local magnification (creating mechanical anti-reverse); Remove the auxiliary wires; The self-locking method of the suspension suture described in this invention is not limited to the double-clamping flap, positioning groove, or slider pressure structure shown in the embodiments. Any structure that can achieve suspension suture tension adjustment and self-locking after implantation into the scleral layer can be implemented using the same technical concept. Those skilled in the art can also make equivalent substitutions or modifications based on the above structure; all such modifications, without departing from the technical concept of this invention, fall within the protection scope of this invention.

[0053] This invention achieves self-locking fixation of the scleral suspension of the artificial lens through the synergistic effect of the elastic deformation and rebound of the asymmetric double clamping flap structure 31, the guidance and constraint of the suspension line positioning area 61, the guide slider 71, and other fixing structures and methods. It has the advantages of simple structure, convenient implantation, stable fixation, and minimal tissue damage.

[0054] Obviously, the above-described embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A self-locking fixation device for scleral suspension of an artificial lens, characterized in that, The implantable self-locking fixation component includes an anchor body (11), the anchor body (11) includes a front guide portion (21), a middle connecting portion (41) and a rear asymmetric double clamping flap structure (31), the connecting portion (41) is connected to the guide portion (21), and the asymmetric double clamping flap structure (31) is connected to the connecting portion (41). The asymmetric double clamping flap structure (31) is used to form a tissue anti-retraction fit with the scleral tissue through elastic rebound after implantation between the scleral layers. The asymmetric double clamping flap structure (31) includes a first clamping flap (32) and a second clamping flap (33). A suspension wire compression space (51) is formed between the first clamping flap (32) and the second clamping flap (33). A suspension wire (52) can be provided in the suspension wire compression space (51). The first clamping flap (32) and the second clamping flap (33) are used to clamp the suspension wire (52) after implantation, forming a wire anti-retraction fit. An auxiliary traction structure (34) is connected to the asymmetric double clamping flap structure (31). The auxiliary traction structure (34) includes a first auxiliary wire (35) fixedly connected to the first clamping flap (32), and the auxiliary traction structure (34) also includes a second auxiliary wire (36) fixedly connected to the second clamping flap (33).

2. The scleral suspension self-locking fixation device for artificial lenses as described in claim 1, characterized in that, The first clamping petal (32) and the second clamping petal (33) are structures that are raised in the middle and narrowed at both ends, and the first clamping petal (32) and the second clamping petal (33) are slightly open in their natural state.

3. The scleral suspension self-locking fixation device for artificial lenses as described in claim 1, characterized in that, The length of the first clamping petal (32) is greater than the length of the second clamping petal (33).

4. The scleral suspension self-locking fixation device for artificial lenses as described in claim 1, characterized in that, The bottom end face of the inlet (21) is connected to the inlet head (22), which has a blunt conical structure. The front end surface of the inlet head (22) and each guide opening on the outer wall of the inlet (21) are provided with rounded chamfers.

5. The scleral suspension self-locking fixation device for artificial lenses as described in claim 1, characterized in that, The outer wall of the connecting part (41) is provided with an inwardly recessed suspension line positioning area (61), and a suspension line (52) can be provided in the suspension line positioning area (61). The bottom width of the groove of the suspension line positioning area (61) is slightly larger than the diameter of the suspension line (52). The suspension line positioning area (61) is a straight groove or a curved groove.

6. The scleral suspension self-locking fixation device for artificial lenses as described in claim 5, characterized in that, The inner surface of the suspension line positioning area (61) is provided with a friction-enhancing structure, which is a corrugated structure.

7. The scleral suspension self-locking fixation device for artificial lenses as described in claim 1, characterized in that, One end of the connecting part (41) is divided and provided with a guide slider (71). The anchor plug body (11) is provided with a pressure area (72). The bottom of the pressure area (72) and the connecting part (41) form a pressure angle (73). The upper end face of the guide slider (71) is connected to a guide wire (74) that is inclined towards the inside of the anchor plug body (11). The guide wire (74) passes through the first clamping petal (32).

8. A self-locking fixation device for scleral suspension of an intraocular lens as described in any one of claims 1 to 7, characterized in that, The anchor body (11) is a non-cylindrical structure. The outer contour of the anchor body (11) and the inner wall of the interscleral tunnel form a posture constraint, restricting the anchor body (11) from rotating around its axis in the interscleral tunnel.

9. A method for self-locking fixation of scleral suspension with an intraocular lens as described in any one of claims 1 to 7, characterized in that, Includes the following steps: S1. Creating a scleral tunnel: In the predetermined scleral fixation area, a tunnel is made in the scleral layer using a tunneling knife or puncture needle. The depth and length of the tunnel are adapted to the size of the anchor plug body (11). S2, Pre-installed suspension line: One end of the artificial lens suspension wire (52) is passed through the interscleral tunnel, and an appropriate length is reserved for subsequent fixation; S3. Insert the suspension line into the anchor plug body: The suspension line (52) is directly placed into the suspension line compression space (51) between the first clamping petal (32) and the second clamping petal (33); Alternatively, the suspension line (52) may be embedded in the groove of the suspension line positioning area (61) on the outer wall of the connecting part (41); S4. Implanted anchor plug body: Using the auxiliary traction structure (34), namely pulling the first auxiliary wire (35) and the second auxiliary wire (36), the anchor plug body (11) is slowly advanced along the interscleral tunnel; During implantation, the blunt conical tip of the insertion head (22) and the rounded chamfers at each guide port reduce resistance and avoid damage to the suspension wire (52). The first clamping flap (32) and the second clamping flap (33) of the asymmetric double clamping flap structure (31) are deformed by pressure in sequence due to their different lengths. The deformation area is misaligned along the axial direction to avoid stress concentration and make implantation smoother. S5. Elastic rebound and self-locking fixation: When the anchor plug body (11) is fully implanted in the predetermined position, the first clamping flap (32) and the second clamping flap (33) elastically rebound and return to the slightly open state; After rebounding, the double flaps and scleral tissue form a mechanical anti-retraction structure, achieving tissue anti-retraction and preventing the anchor plug from retracting and coming out. At the same time, the suspension line (52) is clamped in the suspension line compression space (51), the suspension line positioning area (61) or the line pressing area (72) to achieve line stop; The organization's backstop and the line's backstop together form a double fixation; S6. Adjust the position and suspension tension of the intraocular lens to ensure that the intraocular lens is centered, the suspension tension is appropriate, and the lens is securely fixed. If adjustments are needed, the auxiliary wire can be used to remove the anchor plug, readjust, and then implant the lens again. After confirming that everything is correct, cut the auxiliary wire and traction wire to retract the remaining end into the tunnel between the scleral layers. S7. After confirming that everything is correct, suture the conjunctiva as needed to end the surgery.

10. The method for self-locking fixation of scleral suspension with an artificial lens as described in claim 9, characterized in that, In step S3, after the suspension line (52) is embedded in the suspension line positioning area (61) groove on the outer wall of the connecting part (41), the step further includes: driving the guide slider (71) to move upward by pulling the guide wire (74), pressing the suspension line (52) to bend and deform at the pressure angle (73) to achieve bending locking.

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