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EP-4081165-B1 - BIOCOMPATIBLE NATURAL POLYMER BASED CARTRIDGE COATING FOR INTRAOCULAR LENS (IOL) IMPLANTATION AND A PRODUCTION METHOD THEREOF

EP4081165B1EP 4081165 B1EP4081165 B1EP 4081165B1EP-4081165-B1

Inventors

  • OYTUN, Faruk
  • ATMACA, Serkan

Dates

Publication Date
20260513
Application Date
20201224

Claims (10)

  1. Coating for intraocular lens (IOL) cartridge; which is developed in order to facilitate implantation of intraocular lenses (IOL), to enable the implantation of intraocular lens (IOL) through the cartridge easily without damaging it, to enable it to be stable during its long shelf life, to be flexible and lubricious; comprising - At least one amine functionalized natural polymer which is selected from a group comprised of chitosan (CHI), O-carboxymethyl chitosan (O-CM-CHI), and mixtures thereof, - At least one carboxylic acid functionalized natural polymer which is selected from a group comprised of hyaluronic acid (HA), carboxymethyl cellulose (CMC), N,O-carboxymethyl (N,O-CM-CHI) chitosan and mixtures thereof, - At least one crosslinking agent
  2. Coating for intraocular lens (IOL) cartridge according to claim 1, wherein polymer solutions are prepared in deionized water solvent.
  3. Coating for intraocular lens (IOL) cartridge according to claim 1, wherein chitosan (CHI) solutions are prepared in 0.5 % acetic acid.
  4. Coating for intraocular lens (IOL) cartridge according to claim 1, comprising 1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) as crosslinking agent.
  5. Coating for intraocular lens (IOL) cartridge according to any one of the preceding claims, comprising 0.1-0.8 % by weight of chitosan (CHI), 0-0.8 % by weight of carboxymethyl cellulose (CMC), 0-0.8 % by weight of hyaluronic acid (HA), and 0-0.25 % by weight of 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC).
  6. Production method of coating for intraocular lens (IOL) cartridge according to any one of the preceding claims, comprising the steps of: i. Applying plasma treatment to intraocular lens (IOL) cartridges for 10-50 seconds at power of 30-90 W, ii. Coating amine functionalized polymer on the surface of the cartridge, iii. Adding the crosslinking agent to the carboxylic acid functionalized polymer, iv. Then, coating carboxylic acid functionalized polymer on the amine functionalized polymer coating on the surface of the cartridge, v. Applying curing process on the coating surfaces.
  7. Production method of coating for intraocular lens (IOL) cartridge according to claim 6, wherein the polymer is applied on the cartridge surface by dropping in the process steps of coating amine functionalized polymer and coating carboxylic acid functionalized polymer on the cartridge surface.
  8. Production method of coating for intraocular lens (IOL) cartridge according to claim 6, wherein the cartridge taken to the centrifuge device is centrifuged to homogeneously distribute the polymer solution and to remove excess solution following the process steps of coating amine functionalized polymer and coating carboxylic acid functionalized polymer on the cartridge surface.
  9. Production method of coating for intraocular lens (IOL) cartridge according to claim 8, wherein centrifuge rotation speed is 250-1750 rpm and its time is 5-40 seconds.
  10. Production method of coating for intraocular lens (IOL) cartridge according to claim 6, wherein curing process is carried out on the coating surfaces at a temperature of 50-80°C for 1-4 hours.

Description

Field of the Invention The present invention relates to biocompatible natural polymer-based coatings which are used as the inner coating material for the cartridge of intraocular lenses (IOL) and facilitate the implantation of lenses. Background of the Invention The natural crystal lens in the human eye loses its transparency over time due to old age, impact or some diseases, and the vision deteriorates with the decrease of light reaching the retina. In this case, intraocular lenses (IOL) are implanted into the eye in place of the natural crystal lens after cataract surgery. An incision is made in the eye during the implantation of intraocular lenses (IOL). This incision should be as small as possible to reduce trauma and accelerate recovery. In the state of the art, these intraocular lenses (IOL) were made of polymethyl methacrylate (PMMA) material in the early days due to its biocompatible feature. Since PMMA is a hard polymer, a 5-7 mm incision was required for its implantation. Since an incision of this size requires suture, it decreases the comfort of the patient and prolongs the healing process. Implantation performed with smaller incision sizes not only eliminates the need for sutures, but also accelerates the healing process of the patient. For this reason, today, acrylic based foldable, flexible intraocular lenses (IOLs) having both hydrophilic and hydrophobic properties are produced. These lenses can be implanted into the eye even in incision sizes of 3 mm or less. Cartridge injector systems are used in cataract surgeries for implanting the lens into the eye. The lens is folded in the cartridge and passed through the small diameter cartridge tunnel, and then unfolded in the lens capsule located in the eye. IOL cartridges are generally produced from polymers such as polyolefin (e.g. polypropylene) having high hydrophobic properties. When the IOL is pushed inside the cartridge made of these polymers having high friction force, the movement of the lens inside the cartridge is prevented. As the pressure increases, IOL which is folded inside the cartridge has a tendency to expand inside the cartridge with the effect of the friction force, and it becomes impossible to come out of the end of the cartridge. In this case, implantation fails and the IOL undergoes physical deformations such as rupture, tear, and scratching. Recently, different methods have been used to minimize the friction in the cartridge and facilitate the implantation of the intraocular lens (IOL) by coming out of the cartridge tip. One of these methods is adding fatty acid esters such as glycerol monostearate (GMS) to the material of the cartridge as a lubricant additive in the production process. The cartridges produced with this method are subjected to high temperatures for the lubricant additive to impregnate into the inner surface of the cartridge. Even though the cartridge to which a lubricant is added provides a very effective slippery coating, these fatty acid esters (lubricant) rise to the surface of the cartridge over time. This lubricant material, which has risen to the surface, may adhere to the surface of the intraocular lens (IOL) during its long shelf life, causing its optical properties to be damaged. Therefore, the shelf life of the cartridges produced by this method should be kept short. Generally during the application, a viscoelastic gel is added between the lens surface and the coated cartridge surface, allowing the lens and the cartridge to be activated and the lens to slide easily inside the cartridge. For example, important risks and disadvantages such as inability to adjust the viscoelastic fluid used for sliding the lens during surgeries, inability to spread viscoelastic gel homogeneously, strains resulting during the delivery of the lens and scratches and deformations occurring in the lens when low amount of viscoelastic gel is used, as well as difficulty in cleaning after the implantation, the risk of changing the optical properties of the lens by covering the surface of the lens when higher amount of viscoelastic gel is used can be experienced. United States patent document no US8323799B2, an application known in the state of the art, discloses that a solution formed by formulating polyvinyl prolidone (PVP) or hyaluronic acid (HA) as a hydrophilic lubricant, a commercial urethane dispersion (NeoRez® R-9330) as a matrix polymer and polyfunctional aziridine as a crosslinking agent is used as an IOL cartridge coating material. Within the scope of the said application, it is stated that the cartridges subjected to plasma treatment are coated with the prepared coating solution and then left to dry overnight at 60°C. Another method known in the art is to apply a polymer-based lubricant film coating on the inner surface of the cartridge. In patent applications US6238799B1 and US6866936B2 made in accordance with this method, mixtures comprising polyacrylates, polymethacrylates, polyurethanes, polyethylene and polypro