Three-piece foldable artificial iris with haptics, its fabrication method, and its intraocular implantation system

Abstract

This patent relates to a three-piece foldable artificial iris with haptics, its manufacturing method, and an intraocular implantation system. The artificial iris includes an iris body with a foldable iris skeleton embedded within it. The cross-sectional area of ​​the iris skeleton at the fold is smaller than that at other locations. An arc-shaped suture is provided on the iris body to assist in fixing the artificial lens. The implantation system includes an injector, a guide needle, and an iris support. The guide needle facilitates the extraction of the anchor expansion portion. The implantation system assists in the implantation of the artificial iris, reducing tissue damage, minimizing intraoperative and postoperative patient discomfort, reducing surgical complexity, and increasing safety.

Description

Technical Field

[0001] This invention belongs to the field of ophthalmic medical devices and relates to a three-piece foldable artificial iris with haptics and an intraocular implantation system. Background Technology

[0002] The iris plays a crucial role in human eye function by controlling the entry of light and confining it to the area surrounding the eye. The iris also has a significant cosmetic function in facial anatomy.

[0003] Congenital or acquired aniridia and iris defects are often accompanied by other important ocular complications. Iris defects can cause morphological damage such as unequal pupil size, color aberration, and pupillary displacement, leading to cosmetic problems, photophobia, and decreased vision, causing serious psychological and physiological harm to patients. Small iris defects can be repaired with sutures. Larger iris defects require the use of an artificial iris for repair.

[0004] Current artificial irises are typically fixed to the remaining iris, the iris root, or the ciliary sulcus via sutures. This surgical method requires complex procedures within the confined space of the eye. The high level of surgical difficulty and significant suture trauma increases the risk of complications associated with artificial iris implantation.

[0005] When other surgeries are needed, the current procedure of removing an artificial iris from inside the eye is very difficult.

[0006] Furthermore, patients whose irises are damaged due to various reasons such as lesions or injuries often also have lens diseases, and may also have lesions or damage to the lens capsule, making it more difficult to fix the intraocular lens (IOL). Patent CN106264787 B discloses an artificial iris for fixing an IOL, but this patent involves setting a protrusion on the artificial iris with a groove on the protrusion. The haptic of the IOL passes through the groove of the protrusion, and the flange of the protrusion prevents the IOL from falling out of the iris septum. This method requires increasing the thickness of the iris, increasing the incision and surgical difficulty during iris implantation. Summary of the Invention

[0007] To address the current technical shortcomings of artificial irises, this invention provides a three-piece foldable artificial iris with haptics and an intraocular implantation system. The foldable iris is inserted into the eye, resulting in a small incision and ease of operation. The use of an injector to push the foldable artificial iris reduces tissue damage, and the guide needle facilitates the extraction of the anchor, minimizing patient discomfort during and after surgery, reducing surgical complexity, and increasing safety.

[0008] To achieve the above objectives, the present invention adopts the following technical solution.

[0009] A three-piece foldable artificial iris with haptics includes an iris body, the iris body being a first annular structure with a first through hole in the middle, the first annular structure having an arc-shaped slit that penetrates the front and rear end faces of the first annular structure, the outer side of the first annular structure having at least two haptics, the ends of the haptics having fixing ports, the fixing ports being detachably equipped with anchors, the anchors including a base that is engaged with the outer wall of the sclera and an expansion head that passes through the outer wall of the sclera and engages with the fixing port; a foldable iris skeleton is embedded inside the first annular structure, the cross-sectional area of ​​the iris skeleton at the crease being smaller than the cross-sectional area of ​​other parts.

[0010] Preferably, the iris skeleton is a second annular structure with a second through hole in the middle. The outer side of the second annular structure is provided with at least two fixing brackets and at least two auxiliary support ribs. The cross-sectional area of ​​the auxiliary support ribs at the fold is smaller than the cross-sectional area of ​​other parts. The two sides of the second annular structure and the two sides of the auxiliary support ribs are folded towards the middle along the fold.

[0011] Preferably, there are two arc-shaped seams, which are distributed symmetrically about the center of the first annular structure.

[0012] This application also discloses a method for preparing a three-piece foldable artificial iris with loops, comprising the following steps:

[0013] Step 1: Use polymethyl methacrylate (PMMA) to integrally mold the iris skeleton, the fixing bracket around the skeleton, the auxiliary support ribs and anchors in a mold;

[0014] Step 2: Place the formed iris skeleton into the iris body mold and use compression molding. Mix the silicone and silicone color masterbatch in a certain proportion until evenly mixed, then inject it into the mold and heat it to form.

[0015] Step 3: Open the mold, remove the product, clean, dry, and sterilize.

[0016] The present invention also discloses an intraocular implantation system for an artificial iris, comprising a foldable artificial iris, an injector, a guide needle, and an iris support as described above.

[0017] Preferably, the injector includes an artificial iris clip and an injector handle connected to each other, and the head end of the injector rod has a forked opening structure.

[0018] Preferably, the front end of the guide pin has a spiral structure.

[0019] Preferably, the head end of the support is provided with a V-shaped fork, and the end of the fork is an upwardly curved arc.

[0020] The mechanism or synergistic effect of this invention is as follows:

[0021] 1. The procedure involves using matching anchors to pass through and fix the sclera to the wall. It is a simple and easy procedure that can be used to repair iris damage and reconstruct pupils caused by various reasons.

[0022] 2. Using an injector to inject a foldable artificial iris can reduce tissue damage. The guide aid helps the expansion head of the matching anchor pass through the fixation port on the iris body, reducing patient pain during and after the operation, reducing the complexity of the operation, and increasing safety.

[0023] 3. The iris body and iris skeleton can be folded inward in three pieces along the crease. The folded artificial lens has a smaller diameter and requires a smaller incision when implanted into the eye.

[0024] 4. The tip of the injector has a forked opening structure, allowing it to enter the artificial iris clip and contact the main body of the folded artificial iris, pushing the artificial iris forward. During this pushing process, it does not contact the loop portion of the artificial iris, thus protecting the integrity of the loop structure.

[0025] 5. The front end of the guide pin has a curved spiral structure, which can fit around the neck of the artificial iris anchor. The expansion head of the guide anchor passes through the silicone fixing port on the artificial iris.

[0026] 6. The retainer is a fork-shaped structure with an open front end, which can be used with a guide pin. It plays a supporting and fixing role when the guide pin guides the expansion head of the anchor nail through the retaining ring.

[0027] Beneficial effects of this invention:

[0028] This invention utilizes matching anchors to pass through and fix to the scleral wall, making the surgery simple and easy to perform. It can be used for iris damage repair and pupil reconstruction caused by various reasons.

[0029] 2. Using a syringe to inject the foldable artificial iris can reduce tissue damage. The guide needle and support device help the expanded part of the matching anchor to pass through the fixation hole on the artificial iris septum, reducing patient pain during and after the operation, reducing the complexity of the operation, and increasing safety. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the structure of an artificial iris after it has unfolded.

[0031] Figure 2 This is a schematic diagram of an artificial iris clamping and fixing an artificial lens.

[0032] Figure 3 This is a schematic diagram of the main view structure of an artificial iris after folding.

[0033] Figure 4 This is a schematic diagram of the left-view structure after the artificial iris is folded;

[0034] Figure 5This is a top view of the structure of an artificial iris after folding.

[0035] Figure 6 This is a schematic diagram of the artificial iris injector.

[0036] Figure 7 This is a schematic diagram of an artificial iris guide.

[0037] Figure 8 This is a schematic diagram of an artificial iris support structure;

[0038] In the diagram, 1. Iris body, 1-1. Fixing opening, 1-2. Arc-shaped slit, 2. Skeleton, 2-1. Auxiliary support rib, 2-2. Fixing bracket, 3. Artificial lens. Detailed Implementation

[0039] 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.

[0040] This invention discloses a three-piece foldable artificial iris with haptics. The iris includes an iris body 1 made of silicone, an iris skeleton 2 made of polymethyl methacrylate (PMMA) embedded inside the iris body 1, and anchors that are matched with the iris body. The iris body is a first annular structure with a first through hole in the middle. Six haptics are symmetrically arranged on the outer side of the first annular structure. Each haptic has a fixing port 1-1 at its end. The expansion head of the matching anchor passes through the fixing port and fixes the iris body to the sclera.

[0041] The artificial iris of this invention has two arc-shaped slits 1-2, each approximately 1 mm long, pre-drilled 4 mm from the center of the first annular structure. These slits penetrate the front and rear ends of the first annular structure, and are symmetrically distributed about the center of the annular structure. Loops for fixing the artificial lens can pass through these slits and clamp and fix the artificial lens 3. The iris skeleton is also an annular structure with a central through-hole. A second annular structure is positioned here, with an inner diameter of approximately 4 mm, a width of approximately 0.5 mm, and a thickness of approximately 0.2-0.3 mm, providing the skeleton with a certain degree of rigidity and support. Two sets of fixing brackets 2-2 are symmetrically arranged at the upper and lower ends of the second annular structure. Each set of fixing brackets consists of two hook-shaped structures arranged symmetrically on the left and right sides. The ends of the hook-shaped structures are located in two planes with the iris skeleton, supporting the iris skeleton and the external iris body against the scleral wall through the hook-shaped structures. Six auxiliary support ribs 2-1 are symmetrically arranged on the left and right sides of the second annular structure to assist in the unfolding of the artificial iris after implantation. The auxiliary support ribs are approximately 0.25mm wide and 0.2mm thick, thinner than the main frame material, and have a certain degree of toughness, allowing them to be folded into three pieces.

[0042] The main framework and auxiliary unfolding structure of the artificial iris have a narrow connection of about 0.3 mm at one-third of the width on both sides. The artificial lens can be folded inward in three pieces along this narrow connection. After folding, the artificial iris has a diameter of about 3.5 mm and a thickness of about 0.9-1.2 mm. When implanted into the eye, only a 3.5-4.0 mm incision or even smaller is required.

[0043] To facilitate the folding of the entire iris into three pieces from the left and right sides towards the center, a crease is made on each of the left and right sides of the second ring structure of the iris skeleton. At this crease, the width of the ring is smaller than that of other parts. A crease is also made on each auxiliary support rib of the iris skeleton, and at this crease, the width of the support rib is smaller than that of other parts.

[0044] The anchor has an expansion head at one end and a base at the other end. The expansion head is engaged with the fixing port, and the base is engaged with the outside of the sclera.

[0045] This invention also discloses a method for preparing the above-mentioned novel foldable silicone artificial iris, comprising the following steps:

[0046] The artificial iris septum frame and fixing loops are integrally formed by casting, thus eliminating the need for further processing such as polishing and drilling.

[0047] The pre-formed skeleton system is placed into an artificial iris mold, and compression molding is used. Various components of silicone and silicone masterbatch are mixed evenly in a specific ratio, then injected into the mold and heated to solidify. After opening the mold and removing the product, it is cleaned, dried, and sterilized to obtain a qualified product. Artificial irises produced using this method have high precision, a smooth surface, require no polishing, and are free of burrs.

[0048] The guide and support are both integrally molded using a casting process, eliminating the need for further processing such as polishing and drilling.

[0049] The present invention also discloses an intraocular implantation system for an artificial iris, the system comprising a foldable artificial iris, an injector, a guide needle, and an iris support as described above.

[0050] The injector includes an injector handle and a fork-shaped structure mounted on the end of the injector handle. The injector handle consists of a housing and an injector rod. By pushing the injector rod, it passes through the housing and connects to the housing in a piston-like manner. The fork-shaped structure at the tip of the injector rod can enter the artificial iris clip and contact the silicone spacer of the folded artificial iris, pushing the artificial iris forward. During the pushing process, it does not contact the loop portion of the artificial iris, thus protecting the integrity of the loop structure.

[0051] The front end of the guide pin has a curved spiral structure with a spiral diameter of about 0.25 mm and an inner diameter of about 0.5 mm. It can rotate to fit around the neck of the artificial iris anchor. The expanded part of the guide anchor passes through the silicone fixing hole on the artificial iris.

[0052] The iris support is a fork-shaped structure with an open front end, approximately 0.5 mm in length and 0.5 mm in opening. It is bent upwards at approximately 45° and can be used with a guide pin. It provides support and fixation when the guide pin guides the expanded part of the anchor pin through the fixing ring.

[0053] The process of iris implantation using this implantation system is as follows:

[0054] (1) Fold the foldable artificial iris and insert it into the artificial iris clip that has been pre-injected with viscoelastic agent, placing the loop at one end of the artificial iris clip at the head end and the other end at the tail end;

[0055] (2) Install the artificial iris clip and the injection handle together;

[0056] (3) Clamp the artificial iris at the tip of the injector at the 11 o'clock position and insert it into the eye through the clear corneal incision. Push the injector rod to move the artificial iris forward until it is fully inserted.

[0057] (4) After the artificial lens unfolds naturally, guide the haptic to the scleral wall at the 1 o'clock and 7 o'clock positions, and insert the guide needle into the eye through the scleral tunnel incision 1.5 mm behind the limbus;

[0058] (5) Insert the expanded portion of the anchor into the scleral wall at the 1 o'clock and 7 o'clock positions, 1.5 mm-2 mm behind the limbus. Pass the guide needle through the expanded portion of the matching anchor and loop it around its neck. Pull out the needle and guide the expanded portion through the silicone ring of the fixation hole. Fix the loop and fixation hole at the other end in the same way.

[0059] (6) The spare fixation port can be used for auxiliary fixation of artificial iris without the need for additional suture fixation.

[0060] (7) If an artificial lens is required, a soft artificial lens is implanted into the posterior part of the artificial iris, and the haptic of the artificial lens passes through the pre-reserved slit on the artificial iris for support and fixation.

[0061] The embodiments and descriptions above are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from its spirit and scope. All such changes and modifications fall within the scope of the present invention as claimed, which is defined by the appended claims and their equivalents.

Claims

1. A band-plate three-piece foldable artificial iris, characterized by, The artificial iris comprises an iris body, which is a first annular structure with a first through hole in the middle. The first annular structure is provided with an arc-shaped slot, which penetrates the front and back end faces of the first annular structure. The outer side face of the first annular structure is provided with at least two hanks, and the end of the hank is provided with a fixing port. The fixing port is detachably provided with an anchor, which comprises a base clamped on the outer wall of the sclera and an expansion head clamped with the fixing port after penetrating the outer wall of the sclera. The first annular structure is internally embedded with a foldable iris skeleton, and the cross-sectional area of the iris skeleton at the crease is smaller than that of other parts. The iris skeleton is a second annular structure with a second through hole in the middle. The outer side face of the second annular structure is provided with at least two fixing supports and at least two auxiliary support ribs. The cross-sectional area of the auxiliary support rib at the crease is smaller than that of other parts. The two sides of the second annular structure and the two sides of the auxiliary support rib are folded towards the middle along the crease.

2. The band-plate three-piece foldable artificial iris according to claim 1, wherein, The arc-shaped slot is two, and the two arc-shaped slots are symmetrically distributed about the center of the first annular structure.

3. A method of manufacturing the ribbon haptics three-piece foldable artificial iris according to claim 1 or 2, characterized in that, The method comprises the following steps: Step 1: using polymethyl methacrylate (PMMA) to integrally form the iris skeleton, the fixing support around the skeleton, the auxiliary support rib and the anchor in a mold; Step 2: placing the formed iris skeleton into an iris body mold, mixing silicone and silicone color masterbatch uniformly in a certain proportion by using mold pressing forming, then injecting into the mold, and heating to form; Step 3: taking out the product after opening the mold, cleaning, drying and sterilizing.

4. An artificial iris intraocular implant system, comprising: The method comprises the steps of: using the artificial iris with hank of claim 1 or 2, a push injector, a guide needle and an iris support device.

5. The artificial iris intraocular implant system of claim 4, wherein, The push injector comprises an artificial iris clamp and a push handle connected with each other, and the head end of the artificial iris clamp is a fork-shaped opening structure.

6. The artificial iris intraocular implant system of claim 4, wherein, The front end of the guide needle is a spiral structure.

7. The artificial iris intraocular implant system of claim 4, wherein, The head end of the iris support device is provided with a V-shaped fork needle, and the end of the V-shaped fork needle is in the shape of an upwardly curved arc. The artificial iris comprises an iris body, which is a first annular structure with a first through hole in the middle. The first annular structure is provided with an arc-shaped slot, which penetrates the front and back end faces of the first annular structure. The outer side face of the first annular structure is provided with at least two hanks, and the end of the hank is provided with a fixing port. The fixing port is detachably provided with an anchor, which comprises a base clamped on the outer wall of the sclera and an expansion head clamped with the fixing port after penetrating the outer wall of the sclera. The first annular structure is internally embedded with a foldable iris skeleton, and the cross-sectional area of the iris skeleton at the crease is smaller than that of other parts. The iris skeleton is a second annular structure with a second through hole in the middle. The outer side face of the second annular structure is provided with at least two fixing supports and at least two auxiliary support ribs. The cross-sectional area of the auxiliary support rib at the crease is smaller than that of other parts. The two sides of the second annular structure and the two sides of the auxiliary support rib are folded towards the middle along the crease. The arc-shaped slot is two, and the two arc-shaped slots are symmetrically distributed about the center of the first annular structure. The method comprises the following steps: Step 1: using polymethyl methacrylate (PMMA) to integrally form the iris skeleton, the fixing support around the skeleton, the auxiliary support rib and the anchor in a mold; Step 2: placing the formed iris skeleton into an iris body mold, mixing silicone and silicone color masterbatch uniformly in a certain proportion by using mold pressing forming, then injecting into the mold, and heating to form; Step 3: taking out the product after opening the mold, cleaning, drying and sterilizing. The method comprises the steps of: using the artificial iris with hank of claim 1 or 2, a push injector, a guide needle and an iris support device. The push injector comprises an artificial iris clamp and a push handle connected with each other, and the head end of the artificial iris clamp is a fork-shaped opening structure. The front end of the guide needle is a spiral structure. The head end of the iris support device is provided with a V-shaped fork needle, and the end of the V-shaped fork needle is in the shape of an upwardly curved arc.

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