Artificial iris implant assembly and prosthetic-based method of operating training thereof

Abstract

The application discloses an artificial iris implanting assembly which comprises a base piece, an optical piece and an artificial lens, the base piece and the optical piece comprise a first state and a second state, the first state is that the base piece and the optical piece are independent of each other, and the second state is that the base piece and the optical piece are sutured to form the assembly; in the second state, the optical piece comprises a limiting piece for fixing the artificial lens, the limiting piece is arranged at the edge of the optical piece, the limiting piece is integrally formed with the optical piece, a haptic of the artificial lens is embedded into the limiting piece, and the optical piece is located between the base piece and the artificial lens; and the base piece is an artificial iris septum.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an artificial iris that can be fitted with an artificial lens assembly. Background Technology

[0002] The iris is a flattened, circular, ring-shaped membrane in the middle layer of the eyeball wall. Located between the cornea and the lens, it is visible through the cornea and is commonly known as the "black part of the eye." In the center is a small round opening called the pupil, through which light enters the eye. The iris is mainly composed of connective tissue and contains pigment, blood vessels, and smooth muscle. The color of the iris varies depending on the amount and distribution of pigment, generally including black, blue, gray, and brown.

[0003] The iris contains smooth muscles arranged around the pupil, called the pupillary sphincter muscles, and smooth muscles arranged radially from the pupil, called the pupillary dilators muscles. The former is innervated by the parasympathetic nervous system, and the latter by the sympathetic nervous system. When strong light shines on the eye, the pupillary sphincter muscles contract, restricting light from entering; when the light is dim, the pupillary dilators muscles dilate the pupil, increasing the amount of light entering. The normal size of the pupil is also related to many factors such as age and refractive state. The pupils of infants under one year old are the smallest, gradually increasing in size, and then gradually decreasing in size after puberty. The pupils of nearsighted eyes are larger than those of farsighted eyes. When a person is in pain or frightened, the pupil dilates, while during sleep, the pupil constricts.

[0004] Iris loss due to various reasons can lead to poor vision and light sensitivity. Implanting an artificial iris can better regulate the light entering the eye, thereby improving vision and comfort.

[0005] As a biological soft tissue material, the iris has viscoelastic properties such as hysteresis, relaxation, creep, and strain rate correlation. An ideal artificial iris material should have similar properties.

[0006] Currently, the artificial iris commonly used in clinical practice is only available in one size, which needs to be cut according to the patient's condition before use, and the sutures need to be positioned by the patient themselves, which is extremely cumbersome and increases the difficulty of the surgery.

[0007] Patients whose iris is damaged due to lesions or trauma often also have lens diseases, including cataracts and possibly capsular bag lesions or damage. For these patients, an intraocular lens and an artificial iris can be implanted separately. However, secondary implantation generally requires fixation via ciliary sulcus sutures. Because the location of the ciliary sulcus is not easily visible, it may lead to asymmetrical lens implantation, causing complications such as astigmatism that is difficult to correct or secondary glaucoma, as well as the risk of ciliary body hemorrhage and damage to trabecular tissue.

[0008] Currently, there are intraocular lenses (IOLs) on the market that integrate an artificial iris, allowing them to function as both an artificial iris and an IOL simultaneously. However, these iris-type IOLs are not suitable for patients with normal lenses, and implantation requires a large corneal incision. Intraoperative intraocular pressure fluctuations are significant, posing a risk of fulminant choroidal hemorrhage and potentially leading to increased corneal neovascularization postoperatively.

[0009] To address the above-mentioned problems, the present invention provides an artificial iris that can be fitted with an artificial lens assembly. Summary of the Invention

[0010] To overcome the problems mentioned in the background art, the present invention adopts the following technical solution: An artificial iris implant assembly includes a base component, an optical component, and an artificial lens. The base component and the optical component have a first state and a second state. In the first state, the base component and the optical component are independent of each other. In the second state, the base component and the optical component are stitched together to form an assembly. In the second state, the optical component includes a limiting member for fixing the artificial lens. The limiting member is disposed at the edge of the optical component and is integrally formed with the optical component. The foot haptics of the artificial lens are embedded in the limiting member. The optical component is located between the base component and the artificial lens.

[0011] Furthermore, the base component includes a first end and a second end. In use, the first end is located above the eyeball, and the second end is located below the eyeball. Both the first and second ends include notches to reduce stimulation of the ciliary processes. This design minimizes stimulation of the ciliary processes while ensuring strength, ensuring aqueous humor flow, and preventing increased intraocular pressure. The notches are located above and below the base component and can be covered by the upper and lower eyelids for aesthetic purposes.

[0012] Furthermore, the notch is a semi-circular through hole, and the notch at the first end and the notch at the second end are symmetrically arranged.

[0013] Furthermore, both the first end and the second end include at least three notches.

[0014] Furthermore, the base component includes a first fixing hole for intraoperative positioning and suture fixation, and the optical component includes a second fixing hole for intraoperative positioning and suture fixation, with the positions of the first fixing hole and the second fixing hole corresponding.

[0015] Furthermore, both the first and second fixation holes are circular, with a diameter of d, where 0.2 ≤ d ≤ 0.3 mm. The placement of the first and second fixation holes facilitates intraoperative positioning and suture manipulation.

[0016] Furthermore, both the base component and the optical component include a left end and a right end. In use, the left end is located on the left side of the eyeball, and the right end is located on the right side of the eyeball. The direction from the first end to the second end is the first direction, and the direction from the left end to the right end is the second direction. Fixing holes one and two are distributed along the first direction on the left and right ends of the base component and the optical component, respectively. This arrangement ensures correct alignment between the base component and the optical component, allowing base components of different specifications to be aligned with optical components of the same specification, preventing obstruction of aqueous humor circulation.

[0017] Furthermore, the base component has at least two fixing holes 1 on its left and right ends, and the optical component has at least two fixing holes 2 on its left and right ends; the fixing holes 1 on the left and right ends of the base component are symmetrical to each other, and the fixing holes 2 on the left and right ends of the optical component are symmetrical to each other.

[0018] Furthermore, the main body of the base component is a circular membrane structure.

[0019] Furthermore, the base component includes a circular through hole in the center, and the position of the through hole corresponds to the position of the pupil.

[0020] Furthermore, the optical component includes a circular through-hole two at its center, the position of which corresponds to the position of the pupil, with through-hole one and through-hole two concentric. The placement of through-hole one and through-hole two leaves space for the pupil.

[0021] Furthermore, the limiting component includes a limiting plate, which includes a baffle one perpendicular to the optical component and a baffle two perpendicular to the baffle one. The baffle one is integrally formed with the optical component, and the baffle one and the baffle two are integrally formed. The baffle one and the baffle two form a limiting groove, and the artificial lens is embedded in the limiting groove.

[0022] Furthermore, both the left and right ends of the optical component include limiting members, and the limiting members at the left and right ends of the optical component are symmetrical to each other.

[0023] Furthermore, both the base component and the optical component are made of silicone. This avoids conflicts at the joints caused by using multiple materials, and this design ensures stable mechanical properties, making it less prone to separation and deformation.

[0024] A prosthesis-based operational training method for an artificial iris implant assembly, involving simple artificial iris implantation, includes the following steps: S1-1. The stitches pass through all the fixing holes of the base component and are then fixed together; S1-2. Make an incision in the eye prosthesis, and unfold the base component after it is inserted into the eye prosthesis through the incision; S1-3. Make four parallel and symmetrical sutures at a distance of 1.5-3.0 mm from the limbus to fix the artificial iris to the scleral wall.

[0025] Furthermore, the suture is 8-0 polypropylene suture.

[0026] Furthermore, the length of the cut is 2.5-3.0 mm.

[0027] Preferably, the length of the cut is 2.8 mm.

[0028] Alternatively, a prosthesis-based operational training method for an artificial iris implant assembly, simultaneously implanting an artificial iris and an artificial lens, includes the following steps: S2-1. The artificial lens is placed on the optical component, and the foot loops at the left and right ends of the artificial lens are embedded in the limiting grooves of the optical component. S2-2. The fixing hole 1 of the base component and the fixing hole 2 of the optical component are correctly aligned. The sewing thread passes through the fixing hole 1 and fixing hole 2 on the left end and the fixing hole 1 and fixing hole 2 on the right end respectively, and the base component and the optical component are sewn and fixed. At the same time, the foot haptic of the artificial lens is fixed to the optical component to form a combination of base component, optical component and artificial lens. S2-3. Make an incision in the eye prosthesis and insert the assembly into the eye prosthesis through the incision; S2-4. Make four parallel, symmetrical sutures 1.5-3 mm from the limbus to fix the assembly to the scleral wall.

[0029] Furthermore, the suture is 8-0 polypropylene suture.

[0030] Furthermore, the length of the cut is 2.5-3.0 mm.

[0031] Preferably, the length of the cut is 2.8 mm.

[0032] The beneficial effects of the present invention are: (1) The basic component, optical component and artificial lens can be assembled and selectively implanted for patients with different diseases. For patients with only iris lesions, only the basic component needs to be implanted; for patients with iris combined with lens lesions, the basic component, optical component and artificial lens are assembled into a combination component and then implanted; (2) The basic component and optical component are made of the same material, avoiding the conflict at the connection caused by using multiple materials. This setting has stable mechanical properties and is not prone to separation and deformation; (3) The incision is small during operation and recovery is fast. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the structure of the basic component of the present invention; Figure 2 This is a top view of the basic component of the present invention; Figure 3 This is a schematic diagram of the structure of the optical component of the present invention; Figure 4 This is a three-dimensional schematic diagram of the optical component of the present invention; Figure 5 This is a side view of the optical component of the present invention; Figure 6 This is a schematic diagram of the combination of the basic component and the optical component of the present invention; Figure 7 This is a three-dimensional schematic diagram of the combination of the basic component and the optical component of the present invention; Figure 8 This is a schematic diagram of the combination of the basic components, optical components, and artificial crystal of the present invention; Figure 9 A schematic diagram of the combined state in which four notches are provided at both the first and second ends of the basic component of the present invention; In the diagram, 1 is the base component; 11 is the fixing hole one; 12 is the through hole one; 2 is the optical component; 21 is the fixing hole two; 22 is the through hole two; 23 is the baffle one; 24 is the baffle two; 3 is the artificial lens; and 31 is the foot haptic. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention are clearly and completely described below through specific examples. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. 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.

[0035] Example 1 like Figure 1-2 As shown, an artificial iris implantation assembly in this embodiment includes a base component 1, an optical component 2, and an artificial lens 3. The base component 1 and the optical component 2 have a first state and a second state. In the first state, the base component 1 and the optical component 2 are independent of each other. In the second state, the base component 1 and the optical component 2 are stitched together to form an assembly. In the second state, the optical component 2 includes a limiting member for fixing the artificial lens 3. The limiting member is disposed on the edge of the optical component 2 and is integrally formed with the optical component 2. The foot haptics of the artificial lens 3 are embedded in the limiting member. The optical component 2 is located between the base component 1 and the artificial lens 3. The base component 1 is an artificial iris diaphragm.

[0036] The base component 1 is specifically configured as follows: Base component 1 includes a first end and a second end. In use, the first end is located above the eyeball, and the second end is located below the eyeball. Both the first and second ends include notches to reduce stimulation of the ciliary processes. This design minimizes stimulation of the ciliary processes while ensuring strength, ensuring aqueous humor flow, and preventing increased intraocular pressure. The notches are located above and below base component 1 and can be covered by the upper and lower eyelids for aesthetic purposes.

[0037] The notch is a semi-circular through hole, and the notch at the first end and the notch at the second end are symmetrically arranged.

[0038] Both the first and second ends include three notches.

[0039] The main body of the base component 1 is a circular membrane structure.

[0040] The diameter of an artificial iris septum is 10-11 mm.

[0041] The thickness of the artificial iris septum is 0.1-0.3 mm, preferably 0.2 mm.

[0042] The center of the base component 1 includes a circular through hole 12, the position of which corresponds to the position of the pupil.

[0043] Example 2 like Figure 3-5 As shown, this embodiment provides specific configurations for optical component 2: The optical component 2 has a circular through-hole 22 at its center, the position of which corresponds to the position of the pupil. Through-hole 12 and through-hole 22 are concentric. The placement of through-hole 12 and through-hole 22 leaves space for the pupil. The diameter of through-hole 12 and through-hole 22 is 3-4 mm.

[0044] The limiting component includes a limiting plate, which includes a first baffle 23 perpendicular to the optical component 2 and a second baffle 24 perpendicular to the first baffle 23. The first baffle 23 is integrally formed with the optical component 2, and the first baffle 23 and the second baffle 24 are integrally formed. The first baffle 23 and the second baffle 24 form a limiting groove, and the artificial lens 3 is embedded in the limiting groove.

[0045] Both the left and right ends of the optical component 2 include limiting components, and the limiting components at the left and right ends of the optical component 2 are symmetrical to each other.

[0046] The thickness of optical component 2 is 0.1-0.25 mm; the diameter of optical component 2 is 10-11 mm.

[0047] Example 3 like Figure 6-8As shown, this embodiment provides a specific configuration for the assembly of the base component 1, the optical component 2, and the artificial lens 3: the base component 1 includes a fixing hole 11 for intraoperative positioning and suture fixation, and the optical component 2 includes a fixing hole 21 for intraoperative positioning and suture fixation, with the fixing hole 11 and the fixing hole 21 corresponding in position.

[0048] Both fixation hole 11 and fixation hole 21 are circular holes, with a diameter of d, where 0.2 ≤ d ≤ 0.3 mm. The placement of fixation holes 11 and 21 facilitates intraoperative positioning and suture manipulation.

[0049] Both the base component 1 and the optical component 2 include a left end and a right end. In use, the left end is located on the left side of the eyeball, and the right end is located on the right side. The direction from the first end to the second end is the first direction, and the direction from the left end to the right end is the second direction. Fixing holes 11 are distributed along the first direction on the left and right ends of the base component 1, and fixing holes 21 are distributed along the first direction on the left and right ends of the optical component 2. This arrangement ensures correct alignment between the base component 1 and the optical component 2, allowing base components 1 of different specifications to be aligned with optical components 2 of the same specification, preventing obstruction of aqueous humor circulation.

[0050] At least two fixing holes 11 are provided on the left and right ends of the base component 1, and at least two fixing holes 21 are provided on the left and right ends of the optical component 2; the fixing holes 11 on the left and right ends of the base component 1 are symmetrical to each other, and the fixing holes 21 on the left and right ends of the optical component 2 are symmetrical to each other.

[0051] Both the base component 1 and the optical component 2 are made of silicone. This avoids conflicts at the joints caused by using multiple materials, and this design ensures stable mechanical properties, making it less prone to separation and deformation. Silicone masterbatch is added to both base component 1 and optical component 2 to simulate iris color and block light, while ultraviolet absorbers are also added to reduce the amount of ultraviolet radiation entering the eye.

[0052] like Figure 9 As shown, with Figure 1-8 The difference lies in the number of notches in base component 1. Figure 9 The base component 1 has four notches at both the first and second ends.

[0053] Example 4 Training methods for simple artificial iris implantation: A prosthesis-based operational training method for an artificial iris implant assembly includes the following steps: S1-1, The sewing thread passes through all the fixing holes 11 of the base component 1 and is fixed; S1-2. Make an incision in the eye prosthesis, and unfold the base component 1 after it is inserted into the eye prosthesis through the incision; S1-3. Make four parallel and symmetrical sutures at a distance of 1.5-3.0 mm from the limbus to fix the artificial iris to the scleral wall.

[0054] The sutures are made of 8-0 polypropylene.

[0055] The length of the incision is 2.5-3.0 mm.

[0056] Preferably, the length of the cut is 2.8 mm.

[0057] Example 5 Simultaneous implantation of artificial iris and artificial lens 3: Operational training method: A prosthesis-based operational training method for an artificial iris implant assembly includes the following steps: S2-1, The artificial lens 3 is placed on the optical component 2, and the foot grooves 31 at the left and right ends of the artificial lens 3 are embedded in the limiting grooves of the base component 1; S2-2. The fixing hole 11 of the base component 1 and the fixing hole 21 of the optical component 2 are correctly aligned. The sewing thread passes through the fixing hole 11 and fixing hole 21 on the left end and the fixing hole 11 and fixing hole 21 on the right end respectively, and the base component 1 and the optical component 2 are sewn and fixed. At the same time, the foot 31 of the artificial lens 3 is fixed to the optical component 2, forming a combination of base component 1, optical component 2 and artificial lens 3. S2-3. Make an incision in the eye prosthesis and insert the assembly into the eye prosthesis through the incision; S2-4. Make four parallel, symmetrical sutures 1.5-3 mm from the limbus to fix the assembly to the scleral wall.

[0058] The sutures are made of 8-0 polypropylene.

[0059] The length of the incision is 2.5-3.0 mm.

[0060] Preferably, the length of the cut is 2.8 mm.

[0061] The above description of the embodiments is only for understanding the present invention. It should be noted that those skilled in the art can make several modifications to the present invention without departing from the principles of the invention, and these modifications will also fall within the protection scope of the claims of the present invention.

Claims

1. An artificial iris implant assembly, comprising a base component, an optical component, and an artificial lens, characterized in that, The base component and the optical component include a first state and a second state. In the first state, the base component and the optical component are independent of each other. In the second state, the base component and the optical component are stitched together to form an assembly. In the second state, the optical component includes a limiting member for fixing the artificial lens. The limiting member is located at the edge of the optical component and is integrally formed with the optical component. The foot haptics of the artificial lens are embedded in the limiting member, and the optical component is located between the base component and the artificial lens. The base component is an artificial iris septum. The basic component includes a first end and a second end. In the use state, the first end is located above the eyeball, and the second end is located below the eyeball. Both the first end and the second end include a notch for reducing stimulation of the ciliary process, ensuring the flow of aqueous humor, and being covered by the upper and lower eyelids. The notch is a semi-circular through hole, and the notch at the first end and the notch at the second end are symmetrically arranged. The base component includes a first fixing hole for intraoperative positioning and suture placement, and the optical component includes a second fixing hole for intraoperative positioning and suture placement. The positions of the first fixing hole and the second fixing hole correspond to each other. Both the base component and the optical component include a left end and a right end. In the usage state, the left end is located on the left side of the eyeball, and the right end is located on the right side of the eyeball. The direction from the first end to the second end is the first direction, and the direction from the left end to the right end is the second direction. The first fixing holes are distributed along the first direction on the left and right ends of the base component, and the second fixing holes are distributed along the first direction on the left and right ends of the optical component. The left and right ends of the base component each have at least two first fixing holes, and the left and right ends of the optical component each have at least two second fixing holes. The first fixing holes on the left and right ends of the base component are symmetrical to each other, and the second fixing holes on the left and right ends of the optical component are symmetrical to each other. The limiting component includes a limiting plate, which includes a baffle one perpendicular to the optical component and a baffle two perpendicular to the baffle one. The baffle one is integrally formed with the optical component, and the baffle one and the baffle two are integrally formed. The baffle one and the baffle two form a limiting groove. Foot grommets are provided at the left and right ends of the artificial lens, and the foot grommets are embedded in the limiting groove of the optical component. Both the base components and optical components are made of silicone.

2. The artificial iris implant assembly according to claim 1, characterized in that, The base component includes a circular through hole in the center, and the position of the through hole corresponds to the position of the pupil.

3. The artificial iris implant assembly according to claim 2, characterized in that, The optical component includes a circular through hole two in the center, the position of which corresponds to the position of the pupil, and the through hole one and through hole two are concentric.

4. A prosthesis-based operational training method for the artificial iris implant assembly according to any one of claims 1-3, characterized in that, Simultaneous implantation of an artificial iris and an artificial lens includes the following steps: S2-1. The artificial lens is placed on the optical component, and the foot loops at the left and right ends of the artificial lens are embedded in the limiting grooves of the optical component. S2-2. The fixing hole 1 of the base component and the fixing hole 2 of the optical component are correctly aligned. The sewing thread passes through the fixing hole 1 and fixing hole 2 on the left end and the fixing hole 1 and fixing hole 2 on the right end respectively, and the base component and the optical component are sewn and fixed. At the same time, the foot haptic of the artificial lens is fixed to the optical component to form a combination of base component, optical component and artificial lens. S2-3. Make an incision in the eye prosthesis and insert the assembly into the eye prosthesis through the incision; S2-4. Make four parallel, symmetrical sutures 1.5-3 mm from the limbus to fix the assembly to the scleral wall.

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