An umbrella-shaped mirror column-based keratoprosthesis and a preparation process thereof

Abstract

The application discloses an umbrella-shaped mirror column-based artificial cornea, which comprises a support and a mirror column connected with the support, wherein the support comprises a main body structure in a spherical surface structure, a middle part of the main body structure is provided with an opening, the mirror column is arranged in the opening, a micro-porous gap is formed on the circumferential surface of the main body structure, the top end surface of the mirror column is formed in an arc-shaped umbrella structure, and the bottom end surface of the mirror column is formed in a concave spherical surface structure. The application further discloses a preparation process of the artificial cornea. The artificial cornea is provided with the micro-porous gap on the circumferential surface of the main body structure, so that the healing tissue can pass through the micro-porous gap, the combination force between the support and the cornea is increased, and the stability is improved. In addition, the arc-shaped umbrella structure formed on the top end surface of the mirror column can prevent the growing tissue from covering the mirror surface of the mirror column in the later use of the patient, the light can enter the mirror column, the optical function can be normally played, and the occurrence of the anterior membrane complication is reduced.

Description

Technical Field

[0001] This invention relates to a medical device, specifically to an artificial cornea based on an umbrella-shaped lens and its manufacturing process. Background Technology

[0002] An artificial cornea is a product similar to the human cornea, made of medical polymer materials. It consists of two parts: an optical column and a scaffold. The optical column is made of a transparent material with excellent optical properties and stable physicochemical properties, used to replace a cloudy cornea that obstructs the eye's optical pathway after disease. The scaffold acts as a bridge connecting the optical column and surrounding tissues, therefore requiring good tissue compatibility.

[0003] When a person's cornea is damaged and a living donor corneal transplant is not possible, an artificial cornea is needed. It is suitable for patients with relatively good fundus function but corneal damage that precludes corneal transplantation, such as those with pre-existing corneal diseases or injuries, or patients who have experienced multiple failed corneal transplants resulting in bilateral vision loss. Currently, most artificial corneas on the market consist of a framework made of titanium plates or titanium foil and a PMMA lens pillar. However, in clinical practice, because the framework of these artificial corneas is made of titanium plates, their adhesion and stability to the corneal layers are relatively poor, making them prone to detachment. Furthermore, the lens pillar of the artificial cornea has a cylindrical structure, which can easily be covered by healing tissue during later use, preventing light from entering the lens pillar and thus hindering its optical function. Summary of the Invention

[0004] The purpose of this invention is to provide an artificial cornea based on an umbrella-shaped lens and its manufacturing process. The artificial cornea based on the umbrella-shaped lens can perform its optical function normally and reduce the occurrence of anterior membrane complications.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows: an artificial cornea based on an umbrella-shaped lens column, comprising a support and a lens column connected to the support, wherein the support comprises a main body structure with a spherical structure, an opening in the middle of the main body structure, the lens column passing through the opening, micropores forming on the circumferential surface of the main body structure, the top surface of the lens column forming an arc-shaped umbrella structure, and the bottom surface of the lens column forming a concave spherical structure, and after the support and the lens column are installed together, the convex direction of the arc-shaped umbrella structure on the top surface of the lens column is consistent with the convex direction of the spherical structure of the main body structure.

[0006] As a further improvement, the mirror column is made of PMMA material. The mirror column includes a light guide segment, the top of which extends horizontally outward to form an extended surface. The top surface of the light guide segment protrudes in the middle, and the protrusion forms the arc-shaped umbrella structure along the outer end of the extended surface.

[0007] As a further improvement, the mirror column has a stepped cylindrical structure, and the mirror column includes an insertion section, a mounting section formed on the insertion section, and a light guide section formed on the mounting section. The bottom end surface of the insertion section forms the concave spherical structure.

[0008] As a further improvement, a guide surface is formed at the connection between the insertion section and the mounting section, and the outer diameter of the mounting section is equivalent to the inner diameter of the opening.

[0009] As a further improvement, the main structure is made of PMMA material, and several through holes are evenly opened on the periphery of the main structure to form micropores. The through holes are arranged in a ring array on the periphery of the main structure with the center of the hole as the center.

[0010] As a further improvement, the main structure is made of microporous titanium plate or titanium mesh material, and microporous pores are formed on the peripheral surface of the main structure.

[0011] As a further improvement, the outer circumferential dimension of the bracket is 7-8.5mm, and the thickness of the bracket is 0.05-0.5mm.

[0012] As a further improvement, the inner peripheral wall of the opening is provided with an internal thread, and the outer peripheral surface of the mounting section of the mirror column is provided with an external thread that meshes with the internal thread of the opening.

[0013] This invention also discloses a process for preparing an artificial cornea based on an umbrella-shaped lens column, specifically including the following steps:

[0014] S1: The mirror column is prepared by turning on a lathe to make the PMMA material mirror column form a stepped cylindrical structure, with the top surface of the mirror column having an umbrella-shaped structure and the bottom surface of the mirror column forming a concave spherical structure. The mounting section is machined to form the mounting external thread.

[0015] S2: Preparation of the main structure in the scaffold. The PMMA electrospinning plate is prepared by using PMMA electrospinning and 3D printing technology to form the main structure in the scaffold. Then, the easily soluble small molecules are dissolved by physical mixing method to achieve microporous pores on the scaffold.

[0016] S3: The sheet metal is stamped to form a spherical structure with an opening in the center;

[0017] S4: Lathe turning process, which turns the inner peripheral wall of the opening in the main structure to form an internal thread that meshes with the external thread of the mounting section;

[0018] S5: The bracket and the mirror column are assembled, and the mirror column is installed into the opening of the main structure through the external thread on the mounting section of the mirror column.

[0019] The present invention also discloses a process for fabricating an artificial cornea based on an umbrella-shaped lens column, specifically including the following steps:

[0020] S1: The mirror column is prepared by turning on a lathe to make the PMMA material mirror column form a stepped cylindrical structure, with the top surface of the mirror column having an umbrella-shaped structure and the bottom surface of the mirror column forming a concave spherical structure. The mounting section is machined to form the mounting external thread.

[0021] S2: Preparation of the main structure in the scaffold. The microporous titanium plate is prepared by adding inorganic substances such as hydroxyapatite. After the main structure is formed, the inorganic substances are dissolved by solvent to make a titanium plate or titanium mesh with a microporous structure.

[0022] S3: The sheet metal is stamped to form a spherical structure with an opening in the center;

[0023] S4: Lathe turning process, which turns the inner peripheral wall of the opening in the main structure to form an internal thread that meshes with the external thread of the mounting section;

[0024] S5: The bracket and the mirror column are assembled, and the mirror column is installed into the opening of the main structure through the external thread on the mounting section of the mirror column.

[0025] The above-mentioned technical solution of the present invention has the following beneficial effects: The artificial cornea based on the umbrella-shaped lens column of the present invention allows healing tissue to pass through the micropores on the peripheral surface of the main structure of the scaffold, thereby increasing the bonding force and stability between the scaffold and the cornea; secondly, the arc-shaped umbrella structure formed on the top surface of the lens column prevents the continuously growing tissue from climbing up to the lens surface and covering the lens during later use by the patient, making it easier for light to enter the lens column, so as to exert its optical function normally and reduce the occurrence of anterior membrane complications. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the artificial cornea based on the umbrella-shaped lens column of the present invention;

[0027] Figure 2 is a front view of the bracket 10 in the first embodiment of the present invention;

[0028] Figure 3 This is a front view of the main structure 101 of the support 10 in Figure 2;

[0029] Figure 4 for Figure 3 Top view;

[0030] Figure 5 is a front view of the bracket 10 in the second embodiment of the present invention;

[0031] Figure 6 This is a front view of the main structure 101 of the support 10 in Figure 5;

[0032] Figure 7 for Figure 6 Top view. Detailed Implementation

[0033] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings and examples.

[0034] Please see Figures 1 to 4 As shown, the artificial cornea based on an umbrella-shaped lens column in the first embodiment of the present invention includes a stent 10 and a lens column 20 connected in conjunction with the stent 10 for use in corneal transplantation.

[0035] The bracket 10 is used to support and install the mirror post 20. The bracket 10 includes a main structure 101 and a retaining structure 102 formed on the outer periphery of the main structure 101.

[0036] The main structure 101 has a spherical structure. An opening 11 is provided in the middle of the main structure 101. A mirror post 20 is inserted through the opening 11. Specifically, the inner wall of the opening 11 is provided with internal threads for the mirror post 20 to be installed and connected. In this embodiment, the outer circumferential dimension of the bracket 10 is 7-8.5mm and the thickness is 0.05-0.5mm.

[0037] A plurality of through holes 13 are uniformly formed on the circumferential surface of the main structure 101, so that the main structure 101 forms micropores. The micropores on the circumferential surface of the main structure 101 facilitate the passage of healing tissue through the micropores, increasing the bonding force and stability between the scaffold and the cornea, and preventing detachment. In this embodiment, there are ten through holes 13, each with a diameter of 0.5 mm, and they are arranged in a circular array on the circumferential surface of the main structure 101 with the center of the opening 11 as the center.

[0038] The retaining structure 102 is integrally formed on the main structure 101 and is formed in a ring array around the outer periphery of the main structure 101 with the center of the sphere as the center. In this embodiment, the retaining structure 102 is clover-shaped. Please refer to the reference. Figure 2-1 or Figure 5-1 Or biplane, please refer to the relevant documents. Figure 2-2 or Figure 5-2 Various structures, etc.

[0039] The scaffold 10 is made of PMMA material. The main structure 101 is processed by PMMA electrospinning and 3D printing technology to form the scaffold. Then, through physical mixing, the easily soluble small molecules are dissolved to achieve the microporous structure on the scaffold.

[0040] The endoscope column 20 is installed in the opening 11 of the main structure 101. This prevents continuously growing tissue from climbing onto the lens surface of the endoscope column and covering it during later use by the patient. It also facilitates the entry of light into the endoscope column, allowing it to perform its optical function normally and reducing the occurrence of anterior membrane complications. Specifically, the top surface of the endoscope column 20 has a central protrusion, and this protrusion forms an arc-shaped umbrella structure along the outer end of the top surface. The interior of the endoscope column 20 is a solid structure. In this embodiment, the top surface of the endoscope column 20 has an arc-shaped umbrella structure, and the curvature of the arc at the top of the longitudinal section of the endoscope column 20 is 7.6 mm. The chord length corresponding to the arc is 3-6 mm, preferably 4.5 mm. The arc-shaped umbrella structure formed by the top surface of the endoscope column 20 facilitates the fixation and clamping of the stent during surgery. Furthermore, it prevents continuously growing tissue from climbing onto the lens surface of the endoscope column and covering it during later use by the patient. This allows light to enter the endoscope column, enabling it to perform its optical function normally and reducing the occurrence of anterior membrane complications.

[0041] The mirror column 20 is a stepped cylindrical structure made of PMMA material. The mirror column 20 includes an insertion section 21, a mounting section 22 formed on the insertion section 21, and a light guide section 23 formed on the mounting section 22. The insertion section 21, the mounting section 22, and the light guide section 23 are coaxial and their radial dimensions increase sequentially. A guide surface 24 is formed at the connection between the insertion section 21 and the mounting section 22. The outer diameter of the mounting section 22 is equivalent to the inner diameter of the opening 11, and the outer circumferential surface of the mounting section 22 is provided with an external thread that meshes with the internal thread of the opening 11, so that the mirror column 20 is installed in the opening 11.

[0042] The bottom surface of the insertion segment 21 forms a concave spherical structure, and the top surface of the light guide segment 23 forms a convex umbrella-shaped structure. Specifically, the top surface of the light guide segment 23 extends horizontally outward to form an extension surface 25. The convexity of the top surface of the light guide segment 23 forms an arc-shaped structure along the outer end of the extension surface 25. After the bracket 10 and the mirror column 20 are installed together, the convex direction of the arc-shaped umbrella structure on the top surface of the mirror column 20 is consistent with the convex direction of the spherical structure of the main structure 101 of the bracket 10.

[0043] Please refer to the following: Figure 1 and Figure 5- Figure 7 As shown, the artificial cornea based on an umbrella-shaped lens column in the second embodiment of the present invention has a structure that is largely the same as that described in the first embodiment, except that the main structure 101 of the support 10 is made of microporous titanium plate or titanium mesh material.

[0044] The main structure 101 has a spherical shape and micropores are formed on it to allow healing tissue to pass through, thereby increasing the adhesion between the scaffold and the cornea and preventing detachment. An opening 11 is provided in the middle of the main structure 101, and a lens post 20 is inserted through the opening 11. The outer perimeter of the scaffold 10 is 8 mm and the thickness is 0.1 mm.

[0045] In the molding of the main structure 101, inorganic materials such as hydroxyapatite are added. After molding, the inorganic materials are dissolved using a solvent to produce a titanium plate or mesh with a microporous structure. The microporous structure formed on the main structure 101, with each pore having a diameter of 3nm-100μm, allows healing tissue to pass through the micropores, increasing the adhesion and stability between the scaffold and the cornea, and preventing detachment.

[0046] The fabrication process of an umbrella-shaped lenticular artificial cornea includes the following steps:

[0047] Step 1: Preparation of mirror column 20; specifically, lathe turning, with a cutting tool speed of 2000-10000 r / min. In this embodiment, the cutting tool speed is preferably 8000 r / min, to achieve the processing of optical mirror surface and micro-precision structure, so that mirror column 20 forms a stepped cylindrical structure, and the top surface of mirror column 20 has an umbrella-shaped structure and the bottom surface of mirror column 20 forms a concave spherical structure. The mounting section 22 is turned to form the mounting external thread.

[0048] Step 2: Preparation of the main structure 101 in the scaffold 10; specifically including the preparation of microporous titanium plates or PMMA electrospinning plates; the microporous titanium plates are prepared by adding inorganic materials such as hydroxyapatite, and after molding, the inorganic materials are dissolved by solvent to form titanium plates or titanium mesh with microporous structures; the PMMA electrospinning plates are prepared by using PMMA electrospinning and 3D printing technology to form the scaffold, and then by physical mixing methods to dissolve the easily soluble small molecules to achieve microporous pores on the scaffold.

[0049] Step 3: The sheet metal is stamped to form a spherical structure with an opening 11 in the center.

[0050] Step 4: Lathe machining is performed to form an internal thread that meshes with the external thread of the mounting section 22 at the inner peripheral wall of the opening 11 in the middle of the main structure 101.

[0051] Step 5: Install the mirror post 20 into the opening 11 of the main structure 101 using the external thread on the mounting section 22 of the mirror post 20.

[0052] In summary, the artificial cornea based on the umbrella-shaped lens column of this invention utilizes the micropores on the peripheral surface of the main structure 101 of the scaffold 10 to allow healing tissue to pass through the micropores, increasing the bonding force between the scaffold and the cornea. Secondly, the umbrella-shaped structure formed on the top surface of the lens column 20 facilitates the fixation and clamping of the scaffold during surgery. In later use by the patient, it can prevent continuously growing tissue from climbing onto the lens surface of the lens column and covering the lens, allowing light to enter the lens column and exert its normal optical function, thus reducing the occurrence of anterior membrane complications.

[0053] The above-described embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. An artificial cornea based on an umbrella-shaped lens column, comprising a support (10) and a lens column (20) connected and cooperating with the support (10), characterized in that, The bracket (10) includes a main structure (101) with a spherical structure. The main structure (101) has an opening (11) in the middle and the mirror column (20) is provided in the opening (11). Micropores are formed on the circumferential surface of the main structure (101). The top surface of the mirror column (20) forms an arc-shaped umbrella structure and the bottom surface of the mirror column (20) forms a concave spherical structure. After the bracket (10) and the mirror column (20) are installed together, the protrusion direction of the arc-shaped umbrella structure on the top surface of the mirror column (20) is consistent with the protrusion direction of the spherical structure of the main structure (101). The mirror column (20) includes a light guide section (23), the top end of the light guide section (23) extends horizontally outward to form an extension surface (25), the top end of the light guide section (23) protrudes in the middle, and the protrusion forms the arc-shaped umbrella structure along the outer end of the extension surface (25); The mirror column (20) has a stepped cylindrical structure. The mirror column (20) includes an insertion section (21), a mounting section (22) formed on the insertion section (21), and a light guide section (23) formed on the mounting section (22). The bottom end surface of the insertion section (21) forms the concave spherical structure. A guide surface (24) is formed at the connection between the insertion section (21) and the mounting section (22), and the outer diameter of the mounting section (22) is equivalent to the inner diameter of the opening (11); The inner wall of the opening (11) is provided with an internal thread, and the outer surface of the mounting section (22) of the mirror column (20) is provided with an external thread that meshes with the internal thread of the opening (11). The curvature of the arc at the top of the longitudinal section of the mirror column (20) is 7.6 mm, and the chord length corresponding to the arc is 3-6 mm. The outer circumferential dimension of the bracket (10) is 7-8.5mm.

2. The artificial cornea based on an umbrella-shaped lens column according to claim 1, characterized in that: The mirror column (20) is made of PMMA material.

3. The artificial cornea based on an umbrella-shaped lens column according to claim 1, characterized in that: The main structure (101) is made of PMMA material. Several through holes (13) are evenly opened on the periphery of the main structure (101) so that the main structure (101) forms micropores. The several through holes (13) are arranged in a ring array on the periphery of the main structure (101) with the center of the opening (11) as the center.

4. The artificial cornea based on an umbrella-shaped lens column according to claim 1, characterized in that: The main structure (101) is made of microporous titanium plate or titanium mesh material, and microporous pores are formed on the circumferential surface of the main structure (101).

5. The artificial cornea based on an umbrella-shaped lens column according to claim 1, characterized in that: The thickness of the support (10) is 0.05-0.5mm.

6. A process for fabricating an artificial cornea based on an umbrella-shaped lens column, used to fabricate the artificial cornea based on an umbrella-shaped lens column as described in claim 3, characterized in that, Includes the following steps: S1: The mirror column (20) is prepared by turning on a lathe so that the PMMA material mirror column (20) forms a stepped cylindrical structure, and the top surface of the mirror column (20) is an umbrella-shaped structure and the bottom surface of the mirror column (20) forms a concave spherical structure. The mounting section (22) is machined to form an external mounting thread. S2: Preparation of the main structure (101) in the scaffold (10), the preparation of the PMMA electrospinning plate is achieved by PMMA electrospinning and 3D printing technology to form the main structure in the scaffold, and then by physical mixing method to dissolve the easily soluble small molecules to achieve micropores on the scaffold. S3: The sheet metal is stamped to form a spherical structure with an opening (11) in the middle. S4: By turning on a lathe, the inner circumferential wall of the opening (11) of the main structure (101) is turned to form an internal thread that meshes with the external thread of the mounting section (22); S5: The bracket and the mirror column are assembled. The mirror column (20) is installed into the opening (11) of the main structure (101) by the external thread on the mounting section (22) of the mirror column (20).

7. A process for fabricating an artificial cornea based on an umbrella-shaped lens column, used to fabricate the artificial cornea based on an umbrella-shaped lens column as described in claim 4, characterized in that, Includes the following steps: S1: The mirror column (20) is prepared by turning on a lathe so that the PMMA material mirror column (20) forms a stepped cylindrical structure, and the top surface of the mirror column (20) is an umbrella-shaped structure and the bottom surface of the mirror column (20) forms a concave spherical structure. The mounting section (22) is machined to form an external mounting thread. S2: Preparation of the main structure (101) in the support (10), the microporous titanium plate is prepared by adding inorganic materials. After the main structure is formed, the inorganic materials are dissolved by solvent to make a titanium plate or titanium mesh with microporous structure. The inorganic material is hydroxyapatite. S3: The sheet metal is stamped to form a spherical structure with an opening (11) in the middle. S4: By turning on a lathe, the inner circumferential wall of the opening (11) of the main structure (101) is turned to form an internal thread that meshes with the external thread of the mounting section (22); S5: The bracket and the mirror column are assembled. The mirror column (20) is installed into the opening (11) of the main structure (101) by the external thread on the mounting section (22) of the mirror column (20).

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