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EP-4735064-A1 - OPHTHALMIC VISCOELASTIC DEVICE AND CLEAVING DEVICE

EP4735064A1EP 4735064 A1EP4735064 A1EP 4735064A1EP-4735064-A1

Abstract

The invention relates to an ophthalmic viscoelastic device comprising at least one viscoelastic polymer (10) which can be cleaved into polymer chains (12) with a lower molecular weight. The viscoelastic polymer (10) comprises at least two polymer chains (12) that are connected to one another by at least one thermally and/or photochemically cleavable group (14). The invention also relates to a cleaving device (16) comprising means for cleaving at least one thermally and/or photochemically cleavable group (14) of such an ophthalmic viscoelastic device.

Inventors

  • BADUR, Thorben
  • Thaller, Michael

Assignees

  • Carl Zeiss Meditec AG

Dates

Publication Date
20260506
Application Date
20240624

Claims (10)

  1. 1. An ophthalmic viscoelastic device comprising at least one viscoelastic polymer (10) which is cleavable into polymer chains (12) of lower molecular weight, characterized in that the viscoelastic polymer (10) comprises at least two polymer chains (12) which are connected to one another via at least one thermally and/or photochemically cleavable group (14).
  2. 2. Ophthalmic viscoelastic device according to claim 1, characterized in that the polymer chains (12) have a molecular mass between 70 kDa and 200 kDa, in particular between 76 kDa and 190 kDa, and/or that the viscoelastic polymer (10) has an average molecular weight of at least 0.5 MDa, in particular of at least 2.5 MDa.
  3. 3. Ophthalmic viscoelastic device according to claim 1 or 2, characterized in that the at least one viscoelastic polymer (10) comprises at least one formation block from the group (14) hyaluronic acid, alginate, chitosan, methylcellulose, hydroxypropylmethylcellulose, chondroitin sulfate, collagen and gelatin.
  4. 4. Ophthalmic viscoelastic device according to one of claims 1 to 3, characterized in that the at least one viscoelastic polymer (10) comprises polymer chains (12) which are linked to one another end-to-end and/or via side chain positions via the at least one thermally and/or photochemically cleavable group (14).
  5. 5. Ophthalmic viscoelastic device according to one of claims 1 to 4, characterized in that it is designed as a cohesive or dispersive ophthalmic viscoelastic device and/or that a concentration of the at least one viscoelastic polymer (10) based on the total volume of the ophthalmic viscoelastic device is between 0.1 mg/ml and 50 mg/ml and/or that it comprises at least one therapeutic agent, in particular an analgesic and/or an antioxidant, wherein the therapeutic agent is preferably covalently bound to the at least one viscoelastic polymer (10) via at least one thermally and/or photochemically cleavable group (14) and/or is embedded in the viscoelastic polymer (10).
  6. 6. Ophthalmic viscoelastic device according to one of claims 1 to 5, characterized in that it comprises a stabilizing agent, in particular a radical scavenger, and/or magnetic particles, in particular microparticles and/or nanoparticles.
  7. 7. Ophthalmic viscoelastic device according to one of claims 1 to 6, characterized in that at least one thermally and/or photochemically cleavable group (14) is selected from compounds which can be coupled by means of a [2+2] cycloaddition and/or by click chemistry.
  8. 8. Ophthalmic viscoelastic device according to one of claims 1 to 7, characterized in that it is stored in a thermos container and/or in a light-protected container.
  9. 9. A cleavage device (16) comprising means for cleaving at least one thermally and/or photochemically cleavable group (14) of an ophthalmic viscoelastic device according to one of claims 1 to 8.
  10. 10. Cleavage device (16) according to claim 9, characterized in that it comprises as means a light source (20) for generating light with a wavelength that photochemically splits the at least one group (14) and/or that it comprises as means a magnet device for generating a magnetic field, by means of which magnetic particles of the ophthalmic viscoelastic device can be heated to cleave the at least one thermally and/or photochemically cleavable group (14).

Description

Ophthalmic viscoelastic device and splitting device technical field The invention relates to a degradable ophthalmic viscoelastic device and a splitting device for degrading such an ophthalmic viscoelastic device. State of the art Cataracts are a common condition, especially in the elderly, in which the lens of the eye gradually becomes opaque. This clouding of the natural lens leads to a loss of visual acuity. Cataract surgery is required to restore vision. The standard method of removing the cloudy lens nucleus to create a capsular bag for the insertion of an artificial intraocular lens (IOL) is called phacoemulsification, using a device that generates ultrasonic vibrations. Immediately before phacoemulsification, the anterior chamber is usually filled with a so-called ophthalmic viscoelastic device (OVD). The viscoelastic OVD is used as a surgical aid to protect the intraocular tissue (e.g. the corneal endothelium during phacoemulsification), as a space maintainer (e.g. to maintain the anterior chamber of the eye) and to facilitate intraocular interventions, such as performing a controlled capsulorhexis. However, such OVDs are also used in other eye operations, such as corneal transplants or glaucoma operations. OVDs are usually water-based solutions containing viscoelastic polymers such as hyaluronic acid (HA), chondroitin sulfate (CS), hydroxypropylmethylcellulose (HPMC) or mixtures thereof. The viscoelastic composition can be determined by the molecular weight of the polysaccharide dissolved in the solution, the concentration of the polysaccharide and the viscosity of the solution. The rheological properties are strongly dependent on the concentration and molecular mass of the polymers. In general, two types of OVDs are distinguished. Highly viscous, cohesive OVDs hold the space and build up pressure. They are used, for example, to dilate the pupil before the anterior capsular bag of the lens is opened (capsulorhexis). Cohesive OVDs are made of polymers with a high molecular weight. In contrast, less viscous, dispersive OVDs envelop and protect the tissue. One of the most important applications is the construction of an adherent polymer barrier with a layer thickness of about 100 pm to about 1 mm between the corneal endothelium of the anterior chamber of the eye. Disperse OVDs contain polymer chains with a lower molecular weight compared to cohesive OVDs. Both types of OVDs are usually injected at the beginning of the procedure. During lens fragmentation, they can be flushed out of the incision. For this reason, they are refilled before an intraocular lens is implanted, as the anterior chamber must expand for this step. After surgery, the OVDs must be completely removed from the eye. Breaking down and removing the OVD via natural drainage routes would take too long. Over this period, the patient would suffer from greatly increased intraocular pressure. This is not only painful, but can also lead to an increased risk of developing glaucoma. representation of the invention The object of the present invention is to provide an ophthalmic viscoelastic device for use in eye surgery, which reduces the risk of an increase in intraocular pressure after eye surgery. A further object of the invention is to provide a splitting device for such an ophthalmic viscoelastic device. The object is achieved according to the invention by an ophthalmic viscoelastic device according to claim 1 and by a splitting device according to claim 9. Advantageous embodiments with expedient embodiments of the invention are specified in the subclaims, wherein advantageous embodiments of each aspect of the invention are to be regarded as advantageous embodiments of the other aspect of the invention. A first aspect of the invention relates to an ophthalmic viscoelastic device comprising at least one viscoelastic polymer which can be split into polymer chains with a lower molecular weight. According to the invention, the viscoelastic polymer comprises at least two polymer chains which are connected to one another via at least one thermally and/or photochemically cleavable group. In other words, the at least one viscoelastic polymer of the ophthalmic viscoelastic device (OVD) according to the invention consists of two or more shorter-chain polymer chains which are each connected to one another via at least one thermally and/or photochemically cleavable group, whereby predetermined "predetermined breaking points" are realized. In contrast to hydrolytically cleavable polymers, for example, the viscoelastic polymer of the OVD according to the invention can basically be designed to be stable under biological conditions in the capsular bag or in the eye of the patient and can only be specifically fragmented after an external thermal and/or photochemical stimulus. When the viscoelastic polymer is split into shorter-chain polymer chains, preferably no pharmaceutically active fragments are formed. Instead, the viscoelastic polymer can be specifi