Foldable artificial iris

Abstract

The present application provides a kind of foldable artificial iris, including flexible iris body, the iris body is foldable first annular structure, the outside of the first annular structure is symmetrically provided with at least two elastic fixing ring, the elastic fixing ring is configured with anchor, the anchor includes the base that is clamped in scleral wall, the base is connected with anchor stem, the other end of the anchor stem is provided with expansion head, the expansion head is inwards after being penetrated through scleral wall and is connected with elastic fixing ring;The inside of the first annular structure is embedded with iris skeleton.This artificial iris is implanted by folding, and is unfolded after implantation, so that the operation is simple and easy to operate, implantation and removal are convenient, utilize the anchor of matched set and be fixed on the scleral wall, so as to avoid the operation of suture fixation, the damage to surrounding tissue is small, is used for the iris damage repair and pupil reconstruction caused by various reasons.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of ophthalmic medical devices, and relates to an artificial iris for repairing a defective iris, in particular to a foldable artificial iris. BACKGROUND

[0002] The iris plays a key role in the function of the human eye by controlling the entry of light and limiting it to the para-ocular region. The iris also has a significant cosmetic effect in facial anatomy.

[0003] Congenital or acquired aniridia and iris defects often cause other important ocular complications. Iris defects can cause morphological damage such as anisocoria, chromatic aberration and ectopia of the pupil, causing cosmetic disorders, photophobia and decreased vision, causing serious psychological and physiological damage to the patient. Small iris defects can be repaired with sutures. Larger iris defects require repair using an artificial iris.

[0004] Existing cosmetic anterior chamber iris devices are mostly made of hard and non-foldable materials. Hard cosmetic artificial irises require a large surgical incision, are difficult to implant, and can cause damage to the eye, causing serious complications such as corneal failure, iritis, glaucoma, iris atrophy, ectopia of the pupil and early cataract.

[0005] Existing artificial irises are usually fixed to the residual iris or the iris root or the ciliary sulcus by suturing. This method is difficult to operate, causes large suture trauma, and increases the risk of complications of artificial iris implantation. When other surgery is required, it is difficult to remove the artificial iris. SUMMARY

[0006] In view of the technical defects of the existing foldable artificial iris, the present application provides a three-segment foldable artificial iris with a haptic, which is implanted in a folded state and then unfolded after implantation, making the operation simple and easy to perform, and facilitating implantation and removal. The supporting anchor is used to penetrate and fix the scleral wall, thereby avoiding the operation of suture fixation, causing less damage to the surrounding tissue, and being used for iris damage repair and pupil reconstruction caused by various reasons.

[0007] To achieve the above-mentioned purposes, the present application adopts the following technical solutions.

[0008] A foldable artificial iris comprises a flexible iris body, the iris body is a foldable first circular ring structure, at least two elastic fixing rings are symmetrically arranged on the outer side of the first circular ring structure, the elastic fixing ring is provided with an anchor, the anchor comprises a base clamped on the scleral wall, the base is connected with an anchor rod, the other end of the anchor rod is provided with an expansion head, the expansion head is clamped with the elastic fixing ring after penetrating the scleral wall inward, and an iris skeleton is embedded in the inside of the first circular ring structure.

[0009] Preferably, the iris framework is a second circular ring structure coaxially arranged with the first circular ring structure, the second circular ring structure has an outer shape smaller than that of the first circular ring structure, and the outer side of the second circular ring structure is symmetrically provided with at least two fixed supports protruding from the outer side of the first circular ring structure.

[0010] Preferably, the fixed support is provided with a bent portion at an end away from the second circular ring structure, and an angle between an axis of the bent portion and a plane where the second circular ring structure is located is greater than 0 degrees and less than 90 degrees.

[0011] Preferably, the outer side of the second circular ring structure is also symmetrically provided with at least two foldable auxiliary support ribs in a region outside the fixed supports.

[0012] Preferably, the auxiliary support ribs are distributed in a radial or parallel manner along the outer side of the second circular ring structure.

[0013] Preferably, the outer end points of two mutually symmetrical auxiliary support ribs are less than the outer circle diameter of the first circular ring structure.

[0014] Preferably, the inner diameter of the first circular ring structure is less than the inner diameter of the second circular ring structure.

[0015] Preferably, the cross sections of the first circular ring structure and the second circular ring structure are rectangular or elliptical.

[0016] Preferably, the outer circle diameter of the first circular ring structure is less than the diameter of the cornea.

[0017] Preferably, the iris framework and the anchor are both made of polymethyl methacrylate (PMMA), and the iris body is made of silicone color master material. The silicone color master is synthesized by a colorant and silicone, and the artificial iris is basically not transparent, which can overcome the phenomenon of glare and photophobia and improve visual acuity.

[0018] The working process of the present application is as follows:

[0019] First, fold the iris body to the center on both sides, implant the folded iris into the eye, and the artificial iris can be naturally unfolded under the assistance of the auxiliary support rib after being implanted into the eye. The fixed support on the iris framework supports the iris body in front of the cornea, the expansion head of the anchor passes through the sclera wall and the fixed ring of the iris body, and the expansion head is connected with the fixed ring, so that the iris body is fixed in the sclera and does not contact the surrounding tissue.

[0020] The present application has the following beneficial effects:

[0021] 1. In this invention, the iris body is a flexible circular structure. The internal skeleton supports the iris body, giving it both a certain degree of toughness, rigidity, and support. A fixing ring is set on the outer side of the iris body, and the fixing ring is fixed to the scleral wall by anchors, thus avoiding the need for suture fixation. This makes the surgery simple and easy, with convenient implantation and removal, and minimal damage to surrounding tissues. This is crucial for scleral reconstruction, improving visual quality, separating the anterior and posterior segments, and reconstructing a sclera with a satisfactory aesthetic appearance.

[0022] 2. The outer diameter of the first ring-shaped structure is smaller than the diameter of the cornea. After the artificial iris is fixed, there is a certain gap between it and the surrounding tissue, which can facilitate the flow of aqueous humor and eliminate the need for additional drilling.

[0023] 3. The artificial iris septum involved in this patent is a disc-shaped structure with a central hole, containing silicone masterbatch. The silicone masterbatch is synthesized from colorant and silicone. The artificial iris made from it is basically opaque, which can overcome the phenomena of glare and photophobia and improve visual acuity.

[0024] 4. The iris skeleton is connected to a fixed bracket on the outside, which can act as a support. When the main body of the iris is fixed, it does not come into direct contact with the surrounding tissues, thus avoiding damage to the corneal endothelium.

[0025] 5. Multiple fixing rings are set to assist in fixing the artificial iris when it is unstable.

[0026] 6. The PMMA and silicone materials used in the artificial iris involved in this patent have good biocompatibility with intraocular tissues and are not easily degraded. The matching anchor is made of PMMA. If the artificial iris needs to be removed for any other reason, it is only necessary to cut the anchor base from the outside of the sclera at the connection point with the anchor, which is a simple operation. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the main view structure of the artificial iris implanted in this invention and used in conjunction with the anchor pin;

[0028] Figure 2 This is a top view schematic diagram of the structure of the artificial iris implanted in this invention and used in conjunction with anchors;

[0029] Figure 3 This is a schematic diagram of the iris body in the unfolded state of the present invention;

[0030] Figure 4 This is a schematic diagram of the folded structure of the iris body of the present invention.

[0031] Figure 5 This is a top view of the folded structure of the iris body of the present invention;

[0032] Figure 6 This is a schematic diagram of the left-side view of the iris body in the folded state of the present invention;

[0033] Figure 7 This is a schematic diagram of the anchor structure of the present invention;

[0034] In the diagram: 1. Anchor pin, 1-1. Expansion head, 1-2. Anchor pin rod, 1-3. Base, 2. Iris body, 2-1. Elastic fixing ring, 2-2. First circular ring structure, 3. Iris skeleton, 3-1. Fixing bracket, 3-2. Second circular ring structure, 3-3. Auxiliary support rib, 4. Scleral wall. Detailed Implementation

[0035] The present invention will be further described below with reference to the embodiments and accompanying drawings, but the present invention is not limited to the following embodiments.

[0036] Example 1

[0037] Depend on Figures 1-2 As shown in the schematic diagram of the artificial iris and its supporting anchors, the artificial iris includes an artificial iris body 2, an iris skeleton 3, and supporting anchors 1. The iris body 3 includes a first disc-shaped structure 2-2 with a central hole and an elastic fixing ring 2-1 disposed on the outer side of the first disc-shaped structure. The artificial iris body contains silicone masterbatch, which is synthesized from colorant and silicone. The artificial iris produced is essentially opaque, overcoming glare and photophobia, and improving visual acuity. The outer diameter of the first disc-shaped structure 2-2 is slightly smaller than the diameter of the cornea. This design ensures that it does not directly contact surrounding tissues during fixation, but leaves a certain gap to facilitate the flow of aqueous humor, eliminating the need for additional drilling and avoiding damage to the corneal endothelium. The inner diameter of the first disc-shaped structure 2-2 is sufficient for pupil reconstruction.

[0038] The elastic fixing ring consists of eight rings: one at each of the four vertices of the disc-shaped structure, and one symmetrically positioned above and below each of the left and right vertices in the horizontal direction. Normally, the elastic rings at the top and bottom vertices connect with the anchor pins 1 to achieve fixation. However, if the elastic rings at the top and bottom vertices are unstable in fixing the iris, the six fixing rings on the sides, along with additional anchor pins, can participate in the fixing connection, providing auxiliary fixation.

[0039] An internally embedded iris skeleton 2 provides support for the iris. The skeleton is made of PMMA and features a flat, second annular structure 3-2, providing a certain degree of rigidity and support. At each of the upper and lower ends of the second annular structure, two fixed supports 3-1 are provided, each connected to the PMMA skeleton. These fixed supports are curved cylindrical structures that provide support. Both the upper and lower fixed supports are symmetrically arranged about the elastic fixed ring 2-1. The outer ends of the fixed supports protrude beyond the outer surface of the first annular structure, and a bend is provided at the end of the protrusion. The axis of this bend forms an angle greater than 0 degrees and less than 90 degrees with the plane of the second annular structure. This bend supports the iris within the sclera by supporting the iris skeleton, ensuring that the iris does not directly contact surrounding tissues and facilitating the flow of aqueous humor.

[0040] Six auxiliary support ribs 3-3 are symmetrically arranged on the left and right sides of the second annular structure. These auxiliary support ribs are distributed radially or parallel along the outer surface of the second annular structure to further support the iris body. The connection between the auxiliary support ribs and the second annular structure is movable. When the left and right ends of the iris body are folded towards the center in a three-piece manner, the auxiliary support ribs can fold along with the iris body. After folding, the overall surface area of ​​the iris body is reduced, making it easier to transplant the iris into the sclera with a small incision during surgery. After the folded iris body is placed into the sclera, the auxiliary support ribs naturally unfold from the folded state to the extended state, and the iris body unfolds accordingly under the support of the auxiliary support ribs.

[0041] Anchor 1 is made of PMMA and includes a base 1-3, an anchor rod 1-2, and an expansion head 1-1 connected in sequence. The expansion head passes through the scleral wall and the elastic fixation ring on the artificial iris body to secure the artificial iris, avoiding the need for suture fixation. The length of the anchor rod can be customized according to the thickness of the scleral wall. During implantation, the anchor penetrates the scleral wall and passes through the elastic fixation ring on the artificial iris, securing the artificial iris to the scleral wall via the expansion head. If the artificial iris needs to be removed for any other reason, simply cut the anchor base from the outside of the sclera at the anchor connection point; the operation is simple.

[0042] Example 2

[0043] Combination Figure 3 The image shown is a frontal view of an artificial iris after it has unfolded. Figures 4-6As shown in the schematic diagram of the folded artificial iris, the second annular structure of the main framework of the artificial iris involved in this patent has an inner diameter of approximately 4 mm, a width of approximately 0.5 mm, and a thickness of approximately 0.2-0.3 mm. Three flat auxiliary support ribs are connected to each side of the framework, which can be arranged radially. The width of the auxiliary support ribs is approximately 0.25 mm, and the thickness is approximately 0.2 mm. The main body of the artificial iris is a first disc-shaped structure with a central hole. The diameter of the central hole is approximately 3 mm, the outer diameter is 8 mm-10 mm, and the thickness is 0.3-0.4 mm. After folding, the diameter is approximately 5 mm, and the thickness is approximately 0.9-1.2 mm. Only a 4.0-4.5 mm incision or even smaller is required for implantation into the eye. The elastic fixation ring is connected to the first annular structure by a curved cylindrical structure, and the diameter of the elastic fixation ring is approximately 0.4-0.6 mm. Multiple spare fixation rings are provided on each side of the first annular structure for auxiliary fixation when the artificial iris is unstable.

[0044] Example 3

[0045] like Figure 7 As shown in the schematic diagram of the artificial iris anchor, the artificial iris anchor involved in this patent is made of PMMA and consists of a base and an anchor rod. The base has a diameter of approximately 3mm and a thickness of approximately 0.5mm. The anchor has a diameter of approximately 0.3mm, a length of approximately 3mm-5mm, and an expansion head with a diameter of approximately 0.7mm-10mm located 1mm from the top of the anchor rod.

[0046] The present invention and its embodiments have been described above. This description is not restrictive, and the specific embodiments shown are only a part of the embodiments of the present invention, not all of them. The actual structure is not limited thereto. In short, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A foldable artificial iris, characterized in that, The device includes a flexible iris body, which is a foldable first annular structure. At least two elastic fixing rings are symmetrically arranged on the outer side of the first annular structure. Each elastic fixing ring is equipped with an anchor. Each anchor includes a base that is engaged with the scleral wall. The base is connected to an anchor rod. The other end of the anchor rod is provided with an expansion head. The expansion head penetrates the scleral wall and engages with the elastic fixing ring. An iris skeleton is embedded inside the first annular structure. The iris skeleton is a second annular structure coaxially arranged with the first annular structure. The outer shape of the second annular structure is smaller than that of the first annular structure. At least two fixing brackets are symmetrically arranged on the outer side of the second annular structure, and the fixing brackets protrude from the outer side of the first annular structure. The fixed bracket has a bent portion at the end away from the second annular structure, and the axis of the bent portion forms an angle greater than 0 degrees and less than 90 degrees with the plane where the second annular structure is located. The outer surface of the second annular structure is also symmetrically provided with at least two foldable auxiliary support ribs in the area outside the fixed bracket; The outer surface of the second annular structure is transplanted into the sclera in the area outside the fixation bracket; when the left and right ends of the iris body are folded into three pieces towards the center, the auxiliary support ribs can participate in the folding along with the iris body. After folding, the overall surface area of ​​the iris body is reduced, which makes it easier to transplant the iris into the sclera with a very small incision during surgery. After the folded iris body is placed into the sclera, the auxiliary support ribs naturally unfold from the folded state to the extended state. Under the support of the auxiliary support ribs, the iris body also unfolds.

2. The foldable artificial iris according to claim 1, characterized in that, The auxiliary support ribs are distributed radially or parallelly along the outer side of the second annular structure.

3. A foldable artificial iris according to claim 1, characterized in that, The distance between the outer ends of the two symmetrical auxiliary support ribs is less than the outer diameter of the first annular structure.

4. A foldable artificial iris according to claim 1, characterized in that, The inner diameter of the first annular structure is smaller than the inner diameter of the second annular structure.

5. A foldable artificial iris according to claim 1, characterized in that, The outer diameter of the first annular structure is smaller than the diameter of the cornea.

6. A foldable artificial iris according to claim 1, characterized in that, The iris skeleton and anchors are both made of polymethyl methacrylate (PMMA), and the iris body is made of silicone masterbatch.

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