WO2023098144A1

WO2023098144A1 - Multifocal artificial cornea and preparation process therefor

Info

Publication number: WO2023098144A1
Application number: PCT/CN2022/112489
Authority: WO
Inventors: 于艇
Original assignee: 北京米赫医疗器械有限责任公司
Priority date: 2021-12-02
Filing date: 2022-08-15
Publication date: 2023-06-08
Also published as: CN113952076A

Abstract

A multifocal artificial cornea and a preparation process therefor. The multifocal artificial cornea comprises a stent (10) and a cylinder (20) fitted and connected to the stent (10); the stent (10) comprises a main body structure (101); an opening (11) is formed in the center of the main body structure (101); the cylinder (20) passes through the opening (11); the cylinder (20) comprises a light guide structure (201) having multiple focuses, so as to form a plurality of corresponding diopters by means of the light guide structure (201) during light zooming; the cylinder (20) is made of a PMMA material. By means of the light guide structure (201) having multiple focuses, the multifocal artificial cornea not only enables a patient to have near vision, but also enables the patient to have distance vision. When viewing far, light energy distributed to a far focus is increased, and good distance vision is generated, and when viewing near, due to stimulation of reflection and light, light energy distributed to a near focus is increased, and good near vision is generated, such that both distance vision and near vision are achieved, and real intermediate vision is provided.

Description

A kind of multifocal artificial cornea and its preparation process

technical field

The invention relates to a medical device, in particular to a multi-focus artificial cornea and a preparation process thereof.

Background technique

The artificial cornea is a product similar to the human cornea made of medical polymer materials. The artificial cornea includes two parts: an optical lens column and a bracket. The optical mirror column is made of transparent material with excellent optical properties and stable physical and chemical properties, which is used to replace the cloudy cornea that obstructs the optical pathway of the eyeball after disease; the bracket is equivalent to the bridge connecting the optical mirror column and surrounding tissues, so it is required to have a good Histocompatibility.

When the human cornea is damaged and an artificial cornea is installed, the lens needs to be removed in order to avoid complications. It is suitable for patients with good fundus function but corneal damage who cannot undergo corneal transplantation, such as patients with corneal disease or trauma, etc., who have repeatedly failed corneal transplantation, resulting in binocular failure.

The current public announcement number CN102920532A is a patent for an artificial cornea. The artificial cornea has only one diopter and is a monofocal artificial cornea. Since the optical part of this artificial cornea has no adjustment power, it can only image one area on the retina. If the camera is on, you cannot see far and near objects clearly at the same time. In order to overcome the disadvantages of monofocal artificial cornea, it is necessary to improve this technique.

Contents of the invention

The purpose of the present invention is to provide a multi-focal artificial cornea and its preparation process. The multi-focal artificial cornea can realize far and near vision, not only can see clearly near objects, but also can see distant objects clearly, and has real intermediate vision.

In order to achieve the above object, the technical solution of the present invention is: a multi-focal artificial cornea, including a bracket and a mirror column that is connected with the bracket, the bracket includes a main body structure, and the middle part of the main body structure is provided with an opening, and the inside of the opening is The mirror column is penetrated, and the mirror column includes a light guide structure with multi-focus, so as to form corresponding multiple diopters when the light is zoomed through the light guide structure, and the mirror column is made of PMMA material.

As a further improvement, the light guide structure is a diffractive multi-focus structure, one surface of the diffractive multi-focus light guide structure is a smooth spherical structure, and the other surface is provided with 20-30 concentric circles to form a slope ring structure.

As a further improvement, the light guide structure is a refraction multi-focus structure, one surface of the refraction multi-focus light guide structure forms 3-5 aspheric concentric ring structures, and the other surface is a smooth spherical structure.

As a further improvement, the light guide structure is a graded diffraction-refraction multi-focus structure.

As a further improvement, the central part of the gradient diffraction-refraction multi-focus light guide structure is a diffraction area, and the surrounding part of the light guide structure is a refraction area.

As a further improvement, one side of the gradual diffraction-refraction multi-focus light guide structure is a refraction surface, and the other side of the light guide structure is a diffraction surface.

The invention also discloses a preparation process of a multifocal artificial cornea, which specifically includes the following steps:

S1: The preparation of the mirror column is processed by lathe turning, so that the PMMA material mirror column forms a stepped cylindrical structure, and a diffractive multi-focus light guide structure is formed on the mirror column. One surface of the light guide structure is a smooth spherical surface. structure, the other surface has a microscopic slope ring structure formed by 20 to 30 concentric circles, and the mounting section is turned to form an external thread for installation;

S2: Preparation of the main structure in the bracket, preparation of PMMA electrospinning plate Through PMMA electrospinning and 3D printing technology, the molding of the main structure in the bracket is realized;

S3: The plate is stamped and formed, so that the middle part of the main structure has an opening;

S4: Lathe turning processing, so that the inner peripheral wall of the opening of the main structure is turned to form an internal thread that meshes with the external thread of the installation section;

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.

The present invention also discloses a preparation process of a multifocal artificial cornea according to another embodiment, which specifically includes the following steps:

S1: The preparation of the mirror column is processed by lathe turning, so that the PMMA mirror column forms a stepped cylindrical structure, and a refraction multi-focus light guide structure is formed on the mirror column. One surface of the light guide structure is from 3 to It is composed of 5 aspherical concentric rings, the other surface is a smooth spherical structure, and the mounting section is turned to form an external thread for mounting;

S2: Preparation of the main structure in the bracket. The main structure made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure in the bracket;

The present invention also discloses the preparation process of the multifocal artificial cornea of the third embodiment, which specifically includes the following steps:

S1: The preparation of the mirror column is processed by lathe turning, so that the PMMA material mirror column forms a stepped cylindrical structure, and a gradual diffraction-refraction multi-focus light guide structure is formed on the mirror column. The middle part of the light guide structure is diffraction area, the surrounding part of the light guide structure is a refraction area, and the mounting section is turned to form an external thread for installation;

The present invention also discloses the preparation process of the multifocal artificial cornea of the fourth embodiment, which specifically includes the following steps:

S1: The preparation of the mirror column is processed by lathe turning, so that the PMMA material mirror column forms a stepped cylindrical structure, and a gradual diffraction-refraction multi-focus light guide structure is formed on the mirror column, and one side of the light guide structure is refraction surface, the other side of the light guide structure is a diffractive surface, and the mounting section is turned to form an external thread for installation;

The above-mentioned technical solution of the present invention has the following beneficial effects: the multi-focal artificial cornea of the present invention forms a plurality of diopters correspondingly when the light is zoomed through the multi-focal light guide structure, which not only allows the patient to realize near-distance vision, but also realizes the vision of distant objects. When looking far, the light energy allocated to the far focus is increased to produce better distance vision; when it is necessary to look near, due to reflection and light stimulation, the light energy allocated to the near focus is increased to produce better near vision , to achieve near and far vision, with a real intermediate vision.

As a further improvement, the bracket of the multifocal artificial cornea further includes a clamping structure formed on the periphery of the main structure.

As a further improvement, the height of the slope rings of the slope ring structure is less than 2 μm, the distance between the rings is 0.06 mm to 0.25 mm, and the number of concentric circles of the slope rings on the surface of the light guide structure is 25.

As a further improvement, the clamping structure is formed on the outer periphery of the main structure in an annular array with the center of the sphere of the main structure as the center.

As a further improvement, the clamping structure is a clover-shaped or double-wing structure.

Description of drawings

Fig. 1 is the structural representation of multifocal artificial cornea of the present invention;

2 is a front view of the light guide structure 201 of the mirror column 20 in the first embodiment of the present invention;

Fig. 3 is a side view of Fig. 2;

FIG. 4 is a front view of the light guide structure 201 in the second embodiment of the present invention;

Fig. 5 is a side view of Fig. 4;

FIG. 6 is a front view of the light guide structure 201 in the third embodiment of the present invention;

FIG. 7 is a partial side view of the light guide structure 201 in the fourth embodiment of the present invention;

Figure 8 is a front view of the bracket 10 of the present invention;

FIG. 9 is a front view of another structure of the bracket 10 of the present invention.

Detailed ways

The implementation of the present invention will be described in detail below with reference to the drawings and examples.

Please refer to shown in Fig. 1, a kind of multifocal artificial cornea of the present invention, comprises support 10 and the spectacle column 20 that is connected with support 10, for keratoplasty, not only can allow patient to realize close vision, more Enables vision of distant objects.

8 and 9, the bracket 10 is used to carry and install the mirror column 20. The bracket 10 includes a main structure 101 and a clamping structure 102 formed on the outer periphery of the main structure 101. The main structure 101 is a spherical structure. The middle part of the structure 101 is provided with an opening 11, and the mirror column 20 is pierced in the opening 11. Specifically, the inner peripheral wall of the opening 11 is provided with an internal thread for matching installation and connecting the mirror column 20. In this embodiment, the bracket The peripheral dimension of the stent 10 is 7 to 9 mm, and the thickness is 0.05 to 0.5 mm. Preferably, the peripheral dimension of the stent 10 is 8 mm, and the thickness is 0.2 mm.

The mirror column 20 is installed in the opening 11 of the main structure 101 to achieve multiple diopters corresponding to the light zoom, which not only enables the patient to realize near-distance vision, but also enables the vision of distant objects. Specifically, the mirror column 20 adopts a stepped cylindrical structure made of PMMA material. The mirror column 20 includes an insertion section 21, an installation section 22 formed on the insertion section 21, and a light guide section 23 formed on the installation section 22. The section 21, the installation section 22 and the light guide section 23 are coaxial, and the radial dimensions increase sequentially. A guide surface 24 is formed at the junction of the insertion section 21 and the installation section 22, and the outer diameter of the installation section 22 is equivalent to the inner diameter of the opening 11. , and the outer peripheral surface of the mounting section 22 is provided with an external thread that engages with the internal thread of the hole 11 , so that the mirror column 20 is installed in the hole 11 of the main structure 101 .

The bottom end surface of the insertion section 21 forms a smooth spherical structure, and the mirror post 20 forms a light guide structure 201 with multiple focal points. The multi-focus light guide structure 201 includes a diffraction multi-focus structure, a refraction multi-focus structure or a gradual diffraction-refraction multi-focus structure formed when the light is zoomed.

Please refer to Fig. 2 and Fig. 3, one surface of the multi-focus light guide structure 201 of the diffractive mirror column 20 in the first embodiment of the present invention is a smooth spherical structure 1011, and the other surface is provided with 20 to 30 concentric Microscopic slope ring structure 1012 formed by a circle, the height of the slope ring is less than 2 μm, and the ring spacing is 0.06 mm to 0.25 mm. In this embodiment, there are 25 concentric circles of micro slope rings on the surface of the light guide structure 201. According to the principle of diffraction, a near or far focus is formed. After the incident light passes through the diffractive multi-focus light guide structure 201, it is divided into two focuses. The first is the far focus with a smaller refractive power, and the second is the near focus with a larger refractive power. Its diffraction principle effectively reduces postoperative halo and glare. The near refractive power is determined by the height of the slope ring itself and the distance between the slope rings. Generally, the near refractive power is +4D higher than the far refractive power. At the same time, there is only one The focal point is projected onto the retina. When distant parallel light rays enter the eye, the far focus falls on the retina, forming a clear object image, while the object image formed by the near focus falls in front of the retina, superimposing a blurred object image on the retina, when the nearby scattered light Entering the eye, the near focal point falls behind the retina, and a blurred object image is superimposed on the retina. In the diffractive multi-focus light guide structure 201, there are two types of light distribution for far and near focus, one is equal light energy distribution, 41% for far focus and near focus, and the remaining 18% forms high-order diffraction. The other is unequal distribution of light energy, the two focal points are 70% and 30% respectively (near: far = 7:3 or near: far = 3:7). The biggest advantage of the diffractive multifocal main structure 101 is that one crystal can produce two foci, and its diffractive structure has a large range, and any area can participate in the formation of bifocals, so the far and near focal points are not affected by pupil size and crystal translocation.

Please refer to Fig. 4 and Fig. 5, one surface of the refractive multi-focus light guide structure 201 according to another embodiment of the present invention forms 3 to 5 aspherical concentric ring structures 1013, and the other surface is a smooth spherical structure 1011, different areas of the optical surface have different refractive powers, so that light rays form a wider focus range from far to near after refraction. In this embodiment, there are four aspherical concentric rings on the surface of the light guide structure 201 .

The gradient diffraction-refraction multi-focus light guide structure 201 is divided into two types of refraction-diffraction structures: please refer to FIG. Diffraction zone 1017, the surrounding part of light guide structure 201 is refraction zone 1018; please refer to FIG. The other surface of the light guide structure 201 is the diffractive surface 1016 . The gradual diffractive-refractive multi-focus light guide structure 201 can simultaneously use the refraction and diffraction effects of light to form a near or far focus.

Microporous voids are formed on the peripheral surface of the main structure 101, and the microporous voids on the peripheral surface of the main structure 101 are used to facilitate the healing tissue to pass through the microporous voids, increase the bonding force and stability between the bracket and the cornea, and prevent falling off .

Please refer again to Fig. 8 and Fig. 9, the clamping structure 102 is integrally formed on the main structure 101, and with the center of the sphere of the main structure 101 as the center, an annular array is formed on the outer periphery of the main structure 101. In this embodiment Among them, the clamping structure 102 can be a variety of structures such as a clover-leaf type and a double-wing type.

The main structure 101 of the stent 10 is made of PMMA material or titanium mesh. The main structure 101 is processed through PMMA electrospinning, 3D printing technology and stamping processing to realize the molding of the stent, and then through the physical mixing method, the soluble small molecules Dissolves away, then achieves microporous voids on the scaffold.

The preparation technological process of multifocal artificial cornea comprises the following steps:

Step 1: Preparation of the mirror column 20; specifically, it is turned by a precision numerical control lathe, so that the mirror column 20 forms a stepped cylindrical structure, and a raised multi-focus light guide structure 201 and mirror column 20 are formed on the mirror column 20 The bottom end surface of the bottom surface forms a smooth spherical structure, and the mounting section 22 is turned to form an external mounting thread, specifically, so that the light guide structure 201 forms a diffraction-type multi-focus structure, a refraction-type multi-focus structure or a gradual diffraction-refraction type multi-focus structure; specifically One surface of the diffractive multi-focus light guide structure 201 is a smooth spherical surface, and the other surface has 20 to 30 concentric microscopic slope rings; the first surface of the refractive multi-focus light guide structure 201 is composed of 3-30 Composed of 5 aspherical concentric rings, the other surface is a smooth spherical surface; one side of the gradient diffraction-refraction multi-focus light guide structure 201 is a refraction surface, and the other side of the light guide structure 201 is a diffraction surface; or gradient diffraction-refraction type The central part of the multi-focus light guide structure 201 is a diffraction area, and the surrounding part of the light guide structure 201 is a refraction area.

Step 2: Preparation of the main structure 101 in the bracket 10; the main structure 101 made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure 101 in the bracket, and then the soluble small molecules in the main structure 101 are mixed by physical mixing method Dissolves away, then achieves microporous voids on the scaffold.

Step 3: The plate is stamped and formed, so that the middle part of the main structure 101 is provided with an opening 11 .

Step 4: Turning on a lathe, so that the inner peripheral 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 .

Step 5: The bracket 10 and the mirror column 20 are assembled, and the mirror column is installed into the opening 11 of the main structure 101 through the external thread on the mounting section 22 of the mirror column.

To sum up, the multi-focal artificial cornea of the present invention forms multiple diopters correspondingly when the light is zoomed through the multi-focal light guide structure, which not only allows the patient to realize near-distance vision, but also enables the vision of distant objects; when looking far When the light energy allocated to the far focus is increased to produce better distance vision, when it is necessary to see near, due to the stimulation of reflection and light, the light energy allocated to the near focus is increased to produce better near vision and realize the vision of the far and near ends , with true intermediate vision. Secondly, it has good biocompatibility and good optical resolution. The spectral projection characteristics are consistent with natural crystals. There is no spherical aberration. It can provide functional vision in all visual ranges and minimize glare. And no color difference.

The above-mentioned embodiments are only descriptions of preferred implementations of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, those skilled in the art may make various modifications to the technical solutions of the present invention. and improvements, all should fall within the scope of protection determined by the claims of the present invention.

Claims

A multifocal artificial cornea, characterized in that it comprises a bracket (10) and a mirror post (20) mated with the bracket (10), the bracket includes a main body structure (101), and the middle part of the main body structure (101) An opening (11) is provided, the mirror column (20) is arranged in the opening (11), and the mirror column (20) includes a light guide structure (201) with multiple focal points, so that the light guide structure (201) The corresponding multiple diopters are formed when the light is zoomed, and the mirror column (20) is made of PMMA material.
The multifocal artificial cornea according to claim 1, characterized in that: the light guide structure (201) is a diffractive multifocal structure, and one side of the diffractive multifocal light guide structure (201) is a smooth spherical structure ( 1011), the other side is provided with 20-30 concentric circles to form a slope ring structure (1012).
The multifocal artificial cornea according to claim 1, characterized in that: the light guide structure (201) is a refraction multifocal structure, and one surface of the refraction multifocal light guide structure (201) forms 3 to 5 An aspherical concentric ring structure (1013), and the other surface is a smooth spherical structure (1011).
The multifocal artificial cornea according to claim 1, characterized in that: the light guide structure (201) is a gradient diffraction-refraction multifocal structure.
The multifocal artificial cornea according to claim 4, characterized in that: the middle part of the gradual diffraction-refractive multifocal light guide structure (201) is a diffraction area (1017), and the surrounding part of the light guide structure (201) is the refraction zone (1018).
The multifocal artificial cornea according to claim 4, characterized in that: one side of the gradual diffraction-refractive multifocal light guide structure (201) is a refraction surface (1015), and the other side of the light guide structure (201) is the diffraction surface (1016).
A preparation process for a multifocal artificial cornea, for making the multifocal artificial cornea according to any one of claims 1 and 2, characterized in that it comprises the following steps:

S1: The preparation of the mirror column (20) is processed by lathe turning, so that the mirror column (20) made of PMMA forms a stepped cylindrical structure, and a diffractive multi-focus light guide structure is formed on the mirror column (20). One surface of the light guide structure (201) has a smooth spherical structure, and the other surface has a microscopic slope ring structure formed by 20 to 30 concentric circles, and the mounting section (22) is turned to form an external mounting thread;

S2: preparation of the main structure (101) in the bracket (10), the main structure (101) made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure in the bracket;

S3: stamping and forming the plate, so that the middle part of the main structure (101) is provided with an opening (11);

S4: turning the inner wall of the opening (11) of the main structure (101) to form an internal thread that engages with the external thread of the mounting section (22) by turning on a lathe;

S5: The bracket (10) and the mirror column (20) are assembled, and the mirror column is installed into the opening (11) of the main structure (101) through the external thread on the mounting section (22) of the mirror column.
A preparation process for a multifocal artificial cornea, for making the multifocal artificial cornea according to any one of claims 1 and 3, characterized in that it comprises the following steps:

S1: The preparation of the mirror column (20) is processed by lathe turning, so that the mirror column (20) made of PMMA forms a stepped cylindrical structure, and a refraction-type multi-focus light guide structure is formed on the mirror column (20). One surface of the light guide structure (201) is composed of 3 to 5 aspherical concentric rings, the other surface is a smooth spherical structure, and the mounting section (22) is turned to form an external mounting thread;

S2: preparation of the main structure (101) in the bracket (10), the main structure (101) made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure in the bracket;

S3: stamping and forming the plate, so that the middle part of the main structure (101) is provided with an opening (11);

S4: lathe turning process, the lathe turning process makes the inner peripheral wall of the opening (11) of the main structure (101) be turned to form an internal thread meshing with the external thread of the installation section (22);

S5: The bracket (10) and the mirror column (20) are assembled, and the mirror column is installed into the opening (11) of the main structure (101) through the external thread on the mounting section (22) of the mirror column.
A preparation process for a multifocal artificial cornea, for making the multifocal artificial cornea according to any one of claim 1 or 4 or 5, characterized in that it comprises the following steps:

S1: Preparation of the mirror column (20), which is processed by lathe turning, so that the mirror column (20) made of PMMA forms a stepped cylindrical structure, and a gradual diffraction-refraction multi-focus light guide structure is formed on the mirror column (20) , the middle part of the light guide structure (201) is a diffraction area, the surrounding part of the light guide structure (201) is a refraction area, and the mounting section (22) is turned to form an external thread for installation;

S2: preparation of the main structure (101) in the bracket (10), the main structure (101) made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure in the bracket;

S3: stamping and forming the plate, so that the middle part of the main structure (101) is provided with an opening (11);

S4: Lathe turning processing, so that the inner peripheral 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 installation section (22);

S5: The bracket (10) and the mirror column (20) are assembled, and the mirror column is installed into the opening (11) of the main structure (101) through the external thread on the mounting section (22) of the mirror column.
A preparation process for a multifocal artificial cornea, for making the multifocal artificial cornea according to any one of claim 1 or 4 or 6, characterized in that it comprises the following steps:

S1: Preparation of the mirror column (20), which is processed by lathe turning, so that the mirror column (20) made of PMMA forms a stepped cylindrical structure, and a gradual diffraction-refraction multi-focus light guide structure is formed on the mirror column (20) , one side of the light guide structure (201) is a refraction surface, the other side of the light guide structure (201) is a diffraction surface, and the mounting section (22) is turned to form an external thread for installation;

S2: preparation of the main structure (101) in the bracket (10), the main structure (101) made of PMMA is processed by a precision numerical control lathe to realize the molding of the main structure in the bracket;

S3: stamping and forming the plate, so that the middle part of the main structure (101) is provided with an opening (11);

S4: turning the inner wall of the opening (11) of the main structure (101) to form an internal thread that engages with the external thread of the mounting section (22) by turning on a lathe;

S5: The bracket (10) and the mirror column (20) are assembled, and the mirror column is installed into the opening (11) of the main structure (101) through the external thread on the mounting section (22) of the mirror column.
The multifocal artificial cornea according to claim 1, characterized in that: the bracket (10) further comprises a holding structure (102) formed on the periphery of the main structure (101).
The multifocal artificial cornea according to claim 2, characterized in that: the height of the slope rings of the slope ring structure (1012) is less than 2 μm, the distance between the rings is 0.06 mm to 0.25 mm, and the surface of the light guide structure (201) is There are 25 concentric circles of slope rings.
The multifocal artificial cornea according to claim 11, characterized in that: the clamping structure (102) is formed on the periphery of the main structure (101) in an annular array with the center of the sphere of the main structure (101) as the center.
The multifocal artificial cornea according to claim 13, characterized in that: the clamping structure (102) is a cloverleaf-shaped or double-winged structure.