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WO2024032835A1 - Device for the application of uv radiation to network collagen of the cornea - Google Patents

Device for the application of uv radiation to network collagen of the cornea Download PDF

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Publication number
WO2024032835A1
WO2024032835A1 PCT/CZ2023/050050 CZ2023050050W WO2024032835A1 WO 2024032835 A1 WO2024032835 A1 WO 2024032835A1 CZ 2023050050 W CZ2023050050 W CZ 2023050050W WO 2024032835 A1 WO2024032835 A1 WO 2024032835A1
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WIPO (PCT)
Prior art keywords
corneal
radiation
application
collagen
tunnel
Prior art date
Application number
PCT/CZ2023/050050
Other languages
French (fr)
Inventor
Pavel Stodulka
Martin SRAMKA
Pavel JERMAKOV
Original Assignee
Gemini Eye Clinic A.S.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gemini Eye Clinic A.S. filed Critical Gemini Eye Clinic A.S.
Publication of WO2024032835A1 publication Critical patent/WO2024032835A1/en

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Classifications

    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/0079—Methods or devices for eye surgery using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves
    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00872—Cornea
    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein

Definitions

  • the invention relates to a device for applying UV radiation to cross-link corneal collagen in the Corneal Collagen Cross-linking (CXL) method, used in particular to prevent the onset and progression of corneal ectasia.
  • CXL Corneal Collagen Cross-linking
  • Corneal Collagen Cross-linking is a minimally invasive method to prevent the onset and progression of corneal ectasia, such as keratoconus and ectasia after LASIK or other corneal refractive surgery.
  • the ability of collagen fibrils to form chemical bonds with neighbouring fibrils is referred to as cross-linking.
  • collagen cross-linking occurs naturally with aging due to an oxidative deamination reaction in the end chains of collagen. This fact supports the hypothesis that corneal ectasia often progresses most rapidly in adolescence or early adulthood and tends to stabilize in later life.
  • the CXL procedure begins with applying a riboflavin (vitamin B2) solution to the eye's cornea or under the corneal flap (in the case of the LASIK Extra procedure). This step is followed by exposure to UV-A light, typically with a wavelength of 365 nm, for approximately 30 minutes or, in the case of using a higher-power UV-A source, for a shorter time.
  • UV-A light typically with a wavelength of 365 nm, for approximately 30 minutes or, in the case of using a higher-power UV-A source, for a shorter time.
  • riboflavin creates reactive oxygen species that induce the formation of covalent bonds both between collagen molecules and between collagen molecules and proteoglycans, which restores and preserves part of the cornea's mechanical strength.
  • the epithelial layer of the cornea is generally removed to increase the penetration of riboflavin into the stroma, a procedure known as Epi-Off, which was used in the first published method of corneal CXL referred to as the Dresden Protocol.
  • Epi-Off a procedure known as Epi-Off
  • Trans-Epi pharmacological substances to weaken intraepithelial connections in order to increase the penetration of riboflavin through the epithelium.
  • CXL is the so-called accelerated CXL (aCXL), where a greater power of the UV-A emitter is used to shorten the irradiation time, as well as pulsed CXL, scleral CXL, adapted CXL, etc.
  • the unifying factor of these methods is that they always have the source of UV-A radiation located outside the cornea, typically perpendicularly above it, several to several tens of centimetres away ( Figure 1).
  • Complications of CXL and all its modifications include temporary stromal edema, epithelial damage, pain, haze, corneal scarring, infectious keratitis, and diffuse lamellar keratitis.
  • the device is intended for the innovative CXL method.
  • the principle of the innovation consists of the application of UV-A radiation intrastromally into the created corneal pocket, corneal tunnel, or under the corneal flap.
  • To improve the method's effectiveness it is possible to combine intrastromal UV-A radiation with the supply of oxygen to the corneal pocket, tunnel, or under the flap.
  • a pocket, tunnel, or flap is formed in the cornea.
  • Riboflavin is first applied to the created corneal pocket, tunnel, or under the flap and allowed to penetrate the stroma for a specified period of time. Then, UV-A radiation is applied to the created corneal pocket, tunnel, or under the corneal flap, oxygen might be introduced.
  • the device for the application of UV radiation to cross-link corneal collagen in the Corneal Collagen Cross-linking (CXL) method contains a source of UV-A radiation and a working end with a grip part and a shaped application end for the intrastromal application of UV radiation in the formed corneal pocket, corneal tunnel, or under the corneal flap.
  • CXL Corneal Collagen Cross-linking
  • the device can be supplemented by supplying oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end of the working tip.
  • the working end with the shaped application end can be connected to an external source of UV-A radiation via an optical cable.
  • the source of UV -A radiation is integrated inside the grip part of the working end and is connected to an external power source via an electrical cable.
  • the device allows the radiation to be directed, e.g., either only toward the epithelium or the endothelium; -
  • the application of riboflavin inside the cornea enables more intense penetration;
  • Fig. 1 Radiation application scheme directly inside the cornea in the corneal pocket
  • Fig. 2 Diagram of the device with an external source of UV radiation
  • Fig. 3 Diagram of the device with a UV radiation source integrated inside the grip part of the working end;
  • Fig. 4 Different variants of shape of the working end.
  • the device for applying UV radiation to cross-link corneal collagen 6 in the corneal pocket 6a, tunnel, or under the corneal flap contains a source 1 of UV-A radiation and the working end 2 with the grip part 2b and the shaped application end 2a for the intrastromal application of UV radiation in the created corneal pocket 6a with a diameter of 1 to 10 mm, in the corneal pocket, under the corneal flap with a thickness of 80 to 400 pm and a diameter of 3 to 12 mm, or in the corneal tunnel for intracorneal rings or implants with a diameter of 3 to 11 mm and a width of 0.5 to 5 mm.
  • CXL Corneal Collagen Cross -linking
  • the working end 2 with the shaped application end 2a is connected to the external source 1 of UV-A radiation via an optical cable 3.
  • the working end 2 has a length of 10 to 250 mm and a diameter of 5 to 50 mm.
  • the shaped application end 2a of the working end 2 has the shape according to one of the variants a) to e) shown in Fig. 4, with the fact that its length is 5 to 50 mm and the maximum dimension x conditions the possibility of intrastromal application of UV radiation in the corneal pocket 6a, corneal tunnel, or under the corneal flap is 0.5 to 4 mm.
  • the circular disc on the application end 2a of the working end 2 can either be a part of the working end 2, or it can be separate so that the application end 2a of the working end 2 is inserted into it (shown in Fig. 4e) by a dashed line).
  • the device can also be supplemented by the supply of oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end 2 and the working end 2 in the direction of the arrows 7 (see Fig. 4).
  • the device for applying UV radiation to cross-link corneal collagen 6 in the corneal pocket 6a, tunnel, or under the corneal flap (see Fig. 1) in the Corneal Collagen Cross -linking (CXL) method in another exemplary embodiment according to Fig. 3 has a UV-A source 1 radiation integrated inside the grip part 2b of the working end 2. This source 1 of UV-A radiation is connected to an external power source 5 via an electric cable 4.
  • the shaped application end 2a of the working end 2 is again shaped according to one of the variants shown in Fig. 4, and the device can be completed by supplying oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end 2a of the working end 2 in the direction of the arrows 7 (see Fig. 4).
  • the optical medium of the endings 2 is in a design that scatters light and can, therefore, also have a matte, diffused surface.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Electromagnetism (AREA)
  • Prostheses (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The device is intended for the application of UV radiation to cross-link corneal collagen during the Corneal Collagen Cross-linking (CXL) method, used mainly to prevent the onset and progression of corneal ectasia when intrastromally in the created corneal pocket, corneal tunnel, or under the corneal flap after the application of riboflavin solution, UV-A radiation is performed to produce reactive oxygen species with subsequent induction of the formation of covalent bonds both between collagen molecules and between collagen molecules and proteoglycans to restore and improve the mechanical strength of the cornea. The device contains a source (1) of UV-A radiation and a working end (2) with a grip part (2b) and a shaped application end (2a) for intrastromal application of UV radiation in the corneal pocket, corneal tunnel, or under the corneal flap.

Description

DEVICE FOR THE APPLICATION OF UV RADIATION TO NETWORK COLLAGEN OF THE CORNEA
Field of technology
The invention relates to a device for applying UV radiation to cross-link corneal collagen in the Corneal Collagen Cross-linking (CXL) method, used in particular to prevent the onset and progression of corneal ectasia.
The current state of the technology
Corneal Collagen Cross-linking (CXL) is a minimally invasive method to prevent the onset and progression of corneal ectasia, such as keratoconus and ectasia after LASIK or other corneal refractive surgery. The ability of collagen fibrils to form chemical bonds with neighbouring fibrils is referred to as cross-linking. In the cornea, collagen cross-linking occurs naturally with aging due to an oxidative deamination reaction in the end chains of collagen. This fact supports the hypothesis that corneal ectasia often progresses most rapidly in adolescence or early adulthood and tends to stabilize in later life.
The CXL procedure begins with applying a riboflavin (vitamin B2) solution to the eye's cornea or under the corneal flap (in the case of the LASIK Extra procedure). This step is followed by exposure to UV-A light, typically with a wavelength of 365 nm, for approximately 30 minutes or, in the case of using a higher-power UV-A source, for a shorter time. Upon exposure to UV-A radiation, riboflavin creates reactive oxygen species that induce the formation of covalent bonds both between collagen molecules and between collagen molecules and proteoglycans, which restores and preserves part of the cornea's mechanical strength.
The epithelial layer of the cornea is generally removed to increase the penetration of riboflavin into the stroma, a procedure known as Epi-Off, which was used in the first published method of corneal CXL referred to as the Dresden Protocol. There are protocols without removing the epithelium, the so-called Epi-On, or also Trans-Epi, which use pharmacological substances to weaken intraepithelial connections in order to increase the penetration of riboflavin through the epithelium. Another variant of CXL is the so-called accelerated CXL (aCXL), where a greater power of the UV-A emitter is used to shorten the irradiation time, as well as pulsed CXL, scleral CXL, adapted CXL, etc. The unifying factor of these methods is that they always have the source of UV-A radiation located outside the cornea, typically perpendicularly above it, several to several tens of centimetres away (Figure 1). Complications of CXL and all its modifications include temporary stromal edema, epithelial damage, pain, haze, corneal scarring, infectious keratitis, and diffuse lamellar keratitis.
The essence of the invention
The device, according to the invention, is intended for the innovative CXL method. The principle of the innovation consists of the application of UV-A radiation intrastromally into the created corneal pocket, corneal tunnel, or under the corneal flap. To improve the method's effectiveness, it is possible to combine intrastromal UV-A radiation with the supply of oxygen to the corneal pocket, tunnel, or under the flap. A pocket, tunnel, or flap is formed in the cornea. For this procedure, it is possible to use, e.g., a femtosecond laser or to apply the method during an already performed refractive procedure (typically extraction of a corneal lenticule - Relex SMILE; LASIK; implantation of a corneal ring).
Riboflavin is first applied to the created corneal pocket, tunnel, or under the flap and allowed to penetrate the stroma for a specified period of time. Then, UV-A radiation is applied to the created corneal pocket, tunnel, or under the corneal flap, oxygen might be introduced.
The essence of the invention is that the device for the application of UV radiation to cross-link corneal collagen in the Corneal Collagen Cross-linking (CXL) method contains a source of UV-A radiation and a working end with a grip part and a shaped application end for the intrastromal application of UV radiation in the formed corneal pocket, corneal tunnel, or under the corneal flap.
The device can be supplemented by supplying oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end of the working tip.
Regarding the specific arrangement of the device according to the invention, the working end with the shaped application end can be connected to an external source of UV-A radiation via an optical cable.
In another variant of the arrangement of the device, the source of UV -A radiation is integrated inside the grip part of the working end and is connected to an external power source via an electrical cable.
The advantages of the innovative CXL method and, thus, the benefits of the device according to the invention are given by the following facts:
- There is a targeted application of UV-A radiation to the stroma, which is to be strengthened;
- The possibility of damage to the epithelium sensitive to UV-A radiation is eliminated;
- The device allows the radiation to be directed, e.g., either only toward the epithelium or the endothelium; - The application of riboflavin inside the cornea enables more intense penetration;
- There is no need to remove the epithelium.
Clarification of drawings
The attached drawings serve to clarify the essence of the invention in more detail, where the following represent
Fig. 1 - Radiation application scheme directly inside the cornea in the corneal pocket;
Fig. 2 - Diagram of the device with an external source of UV radiation;
Fig. 3 - Diagram of the device with a UV radiation source integrated inside the grip part of the working end;
Fig. 4 - Different variants of shape of the working end.
Examples of implementation of the invention
Example 1
The device for applying UV radiation to cross-link corneal collagen 6 in the corneal pocket 6a, tunnel, or under the corneal flap (see Fig. 1) in the Corneal Collagen Cross -linking (CXL) method in the exemplary embodiment according to Fig. 2 contains a source 1 of UV-A radiation and the working end 2 with the grip part 2b and the shaped application end 2a for the intrastromal application of UV radiation in the created corneal pocket 6a with a diameter of 1 to 10 mm, in the corneal pocket, under the corneal flap with a thickness of 80 to 400 pm and a diameter of 3 to 12 mm, or in the corneal tunnel for intracorneal rings or implants with a diameter of 3 to 11 mm and a width of 0.5 to 5 mm.
The working end 2 with the shaped application end 2a is connected to the external source 1 of UV-A radiation via an optical cable 3.
The working end 2 has a length of 10 to 250 mm and a diameter of 5 to 50 mm. The shaped application end 2a of the working end 2 has the shape according to one of the variants a) to e) shown in Fig. 4, with the fact that its length is 5 to 50 mm and the maximum dimension x conditions the possibility of intrastromal application of UV radiation in the corneal pocket 6a, corneal tunnel, or under the corneal flap is 0.5 to 4 mm. In the case of variant e), the circular disc on the application end 2a of the working end 2 can either be a part of the working end 2, or it can be separate so that the application end 2a of the working end 2 is inserted into it (shown in Fig. 4e) by a dashed line).
The device can also be supplemented by the supply of oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end 2 and the working end 2 in the direction of the arrows 7 (see Fig. 4).
Example 2
The device for applying UV radiation to cross-link corneal collagen 6 in the corneal pocket 6a, tunnel, or under the corneal flap (see Fig. 1) in the Corneal Collagen Cross -linking (CXL) method in another exemplary embodiment according to Fig. 3 has a UV-A source 1 radiation integrated inside the grip part 2b of the working end 2. This source 1 of UV-A radiation is connected to an external power source 5 via an electric cable 4.
The shaped application end 2a of the working end 2 is again shaped according to one of the variants shown in Fig. 4, and the device can be completed by supplying oxygen to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end 2a of the working end 2 in the direction of the arrows 7 (see Fig. 4).
In this case, the optical medium of the endings 2 is in a design that scatters light and can, therefore, also have a matte, diffused surface.

Claims

C L A I M S The device for the application of UV radiation to cross-link corneal collagen during the Corneal Collagen Cross-linking (CXL) method, used mainly to prevent the onset and progression of corneal ectasia when UV-A radiation is performed intrastromally in the created corneal pocket, corneal tunnel, or under the corneal flap after the application of riboflavin solution, to create a reactive oxygen species with subsequent induction of the formation of covalent bonds both between collagen molecules, and between collagen molecules and proteoglycans to restore and improve the mechanical strength of the cornea, characterized in that this device contains a source of (1) UV-A radiation and working end (2) with a grip part (2b) and a shaped application end (2a) for intrastromal application of UV radiation in the corneal pocket, corneal tunnel, or under the corneal flap. According to claim 1, the device is characterized in that it is supplemented with oxygen supply to the corneal pocket, tunnel, or under the corneal flap through the openings of the application end (2a) of the working end (2). The device, according to claim 1, is characterized in that the working end (2) with the shaped application end (2a) is connected to the external source (1) of UV-A radiation via an optical cable (3). The device, according to claim 1, is characterized in that the source (1) of UV-A radiation is integrated inside the grip part (2b) of the working end (2) and is connected to an external power source (5) utilizing an electric cable (4).
PCT/CZ2023/050050 2022-08-12 2023-08-10 Device for the application of uv radiation to network collagen of the cornea WO2024032835A1 (en)

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CZPV2022-336 2022-08-12
CZ2022-336A CZ2022336A3 (en) 2022-08-12 2022-08-12 Equipment for the application of UV radiation for corneal collagen cross-linking

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106038050A (en) * 2016-02-14 2016-10-26 王昱程 Light-guide stick and handheld cross-linking therapy system
US9937033B1 (en) * 2014-05-12 2018-04-10 Gholam A. Peyman Corneal lenslet implantation with a cross-linked cornea
US20190201710A1 (en) * 2016-09-27 2019-07-04 KeraMed, Inc. System, device, and method for cross-linking corneal tissue
RU199825U1 (en) * 2020-06-01 2020-09-22 Федеральное государственное бюджетное учреждение "Национальный медицинский исследовательский центр глазных болезней имени Гельмгольца" Министерства здравоохранения Российской Федерации (ФГБУ "НМИЦ ГБ им. Гельмгольца" Минздрава России) Corneal crosslinking device
US20220152202A1 (en) * 2015-07-21 2022-05-19 Avedro, Inc. Systems and methods for treatments of an eye with a photosensitizer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9937033B1 (en) * 2014-05-12 2018-04-10 Gholam A. Peyman Corneal lenslet implantation with a cross-linked cornea
US20220152202A1 (en) * 2015-07-21 2022-05-19 Avedro, Inc. Systems and methods for treatments of an eye with a photosensitizer
CN106038050A (en) * 2016-02-14 2016-10-26 王昱程 Light-guide stick and handheld cross-linking therapy system
US20190201710A1 (en) * 2016-09-27 2019-07-04 KeraMed, Inc. System, device, and method for cross-linking corneal tissue
RU199825U1 (en) * 2020-06-01 2020-09-22 Федеральное государственное бюджетное учреждение "Национальный медицинский исследовательский центр глазных болезней имени Гельмгольца" Министерства здравоохранения Российской Федерации (ФГБУ "НМИЦ ГБ им. Гельмгольца" Минздрава России) Corneal crosslinking device

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