WO2023098144A1 - Cornée artificielle multifocale et son processus de préparation - Google Patents

Cornée artificielle multifocale et son processus de préparation Download PDF

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Publication number
WO2023098144A1
WO2023098144A1 PCT/CN2022/112489 CN2022112489W WO2023098144A1 WO 2023098144 A1 WO2023098144 A1 WO 2023098144A1 CN 2022112489 W CN2022112489 W CN 2022112489W WO 2023098144 A1 WO2023098144 A1 WO 2023098144A1
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WO
WIPO (PCT)
Prior art keywords
light guide
mirror column
multifocal
main structure
artificial cornea
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PCT/CN2022/112489
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English (en)
Chinese (zh)
Inventor
于艇
Original Assignee
北京米赫医疗器械有限责任公司
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Application filed by 北京米赫医疗器械有限责任公司 filed Critical 北京米赫医疗器械有限责任公司
Publication of WO2023098144A1 publication Critical patent/WO2023098144A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/145—Corneal inlays, onlays, or lenses for refractive correction
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04—Contact lenses for the eyes
    • G02C7/041—Contact lenses for the eyes bifocal; multifocal
    • G02C7/044—Annular configuration, e.g. pupil tuned
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses

Definitions

  • the invention relates to a medical device, in particular to a multi-focus artificial cornea and a preparation process thereof.
  • 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.
  • the lens 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.
  • 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.
  • 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.
  • 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
  • the other surface is provided with 20-30 concentric circles to form a slope ring structure.
  • 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
  • the other surface is a smooth spherical structure.
  • the light guide structure is a graded diffraction-refraction multi-focus structure.
  • 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.
  • 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;
  • 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;
  • the present invention also discloses the preparation process of the multifocal artificial cornea of the third embodiment, which specifically includes the following steps:
  • 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:
  • 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 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.
  • the light energy allocated to the far focus is increased to produce better distance vision;
  • 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.
  • the bracket of the multifocal artificial cornea further includes a clamping structure formed on the periphery of the main structure.
  • the height of the slope rings of the slope ring structure is less than 2 ⁇ m, 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.
  • 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.
  • the clamping structure is a clover-shaped or double-wing structure.
  • Fig. 1 is the structural representation of multifocal artificial cornea of the present invention
  • FIG. 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.
  • 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.
  • 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.
  • the inner peripheral wall of the opening 11 is provided with an internal thread for matching installation and connecting the mirror column 20.
  • the bracket The peripheral dimension of the stent 10 is 7 to 9 mm, and the thickness is 0.05 to 0.5 mm.
  • 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.
  • 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.
  • 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.
  • 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 ⁇ m, 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
  • 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.
  • 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.
  • 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.
  • one surface of the refractive multi-focus light guide structure 201 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.
  • 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 .
  • 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.
  • 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
  • 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-re
  • 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.
  • 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
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Prostheses (AREA)

Abstract

Cornée artificielle multifocale et son processus de préparation. La cornée artificielle multifocale comprend une endoprothèse (10) et un cylindre (20) ajusté et relié à l'endoprothèse (10) ; l'endoprothèse (10) comprend une structure de corps principal (101) ; une ouverture (11) est formée au centre de la structure de corps principal (101) ; le cylindre (20) passe à travers l'ouverture (11) ; le cylindre (20) comprend une structure de guidage de lumière (201) ayant de multiples foyers, de manière à former une pluralité de dioptries correspondantes au moyen de la structure de guidage de lumière (201) pendant le zoom de la lumière ; le cylindre (20) est constitué d'un matériau PMMA. Au moyen de la structure de guidage de lumière (201) ayant de multiples foyers, la cornée artificielle multifocale permet non seulement à un patient d'avoir une vision de près, mais permet également au patient d'avoir une vision de loin. Lors de la vision de loin, de l'énergie lumineuse distribuée à un foyer éloigné est augmentée, et une bonne vision à distance est générée, et lors de la vision de près, du fait de la stimulation de la réflexion et de la lumière, une énergie lumineuse distribuée à un foyer proche est augmentée, et une bonne vision de près est générée, de telle sorte qu'à la fois une vision de loin et une vision de près sont obtenues, et une vision intermédiaire réelle est fournie.
PCT/CN2022/112489 2021-12-02 2022-08-15 Cornée artificielle multifocale et son processus de préparation WO2023098144A1 (fr)

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CN202111467262.5A CN113952076A (zh) 2021-12-02 2021-12-02 一种多焦点人工角膜及其制备工艺
CN202111467262.5 2021-12-02

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113952076A (zh) * 2021-12-02 2022-01-21 北京米赫医疗器械有限责任公司 一种多焦点人工角膜及其制备工艺

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US20090153794A1 (en) * 2007-12-14 2009-06-18 Iyer Venkatramani S Refractive-diffractive multifocal lens
US20100097569A1 (en) * 2008-10-20 2010-04-22 Advanced Medical Optics, Inc. Multifocal Intraocular Lens
CN102283720A (zh) * 2011-08-01 2011-12-21 姚晓明 一种人工角膜
CN102727324A (zh) * 2012-07-23 2012-10-17 于好勇 人工角膜
CN205286611U (zh) * 2015-12-02 2016-06-08 深圳市第二人民医院 一种人工角膜
CN108348325A (zh) * 2015-10-02 2018-07-31 瑞纳人工晶体有限公司 多焦点透镜
CN111417364A (zh) * 2017-12-28 2020-07-14 梅迪康特医疗工程有限公司 三焦点人造眼镜片及其生产方法
CN113599020A (zh) * 2021-09-15 2021-11-05 姚晓明 一种集晶状体屈光功能的人工角膜
CN113693779A (zh) * 2021-06-01 2021-11-26 天津世纪康泰生物医学工程有限公司 一种具有靶向光场分布的衍射型多焦人工晶状体
CN113952076A (zh) * 2021-12-02 2022-01-21 北京米赫医疗器械有限责任公司 一种多焦点人工角膜及其制备工艺

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090153794A1 (en) * 2007-12-14 2009-06-18 Iyer Venkatramani S Refractive-diffractive multifocal lens
CN201160919Y (zh) * 2008-03-05 2008-12-10 黄一飞 新型分体式人工角膜
US20100097569A1 (en) * 2008-10-20 2010-04-22 Advanced Medical Optics, Inc. Multifocal Intraocular Lens
CN102283720A (zh) * 2011-08-01 2011-12-21 姚晓明 一种人工角膜
CN102727324A (zh) * 2012-07-23 2012-10-17 于好勇 人工角膜
CN108348325A (zh) * 2015-10-02 2018-07-31 瑞纳人工晶体有限公司 多焦点透镜
CN205286611U (zh) * 2015-12-02 2016-06-08 深圳市第二人民医院 一种人工角膜
CN111417364A (zh) * 2017-12-28 2020-07-14 梅迪康特医疗工程有限公司 三焦点人造眼镜片及其生产方法
CN113693779A (zh) * 2021-06-01 2021-11-26 天津世纪康泰生物医学工程有限公司 一种具有靶向光场分布的衍射型多焦人工晶状体
CN113599020A (zh) * 2021-09-15 2021-11-05 姚晓明 一种集晶状体屈光功能的人工角膜
CN113952076A (zh) * 2021-12-02 2022-01-21 北京米赫医疗器械有限责任公司 一种多焦点人工角膜及其制备工艺

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