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EP-4342525-B1 - A DEVICE FOR IMPROVING THE CONDITIONS OF AN EYE

EP4342525B1EP 4342525 B1EP4342525 B1EP 4342525B1EP-4342525-B1

Inventors

  • LAM, David Chuen Chun
  • LEUNG, YUN YUEN

Dates

Publication Date
20260506
Application Date
20230920

Claims (15)

  1. A device for improving a state of an eye in a subject, the device comprising a pressure control module configured and adapted to stretch the cornea, the peripapillary sclera, or the extraocular muscle of the eye to an extent sufficient to measurably change a periocular pressure of the eye, or an intraocular pressure of the eye, or both; wherein the device further comprises: a goggle carrier; a heat pad module configured and adapted to warm a cornea, a peripapillary sclera, or an extraocular muscle of the eye to a threshold value that is above a skin surface temperature of the subject; a radiation module configured and adapted to irradiate one or more tissues of an optic nerve head and the peripapillary sclera in a posterior chamber of the eye with an infra-red radiation having a peak wavelength between 780 nm and 950 nm and with a visible light radiation having a peak wavelength between 550 to 700 nm; and a controller operably connected to the heat pad module, the pressure control module, and the radiation module, the controller configured and adapted to provide heat, pressure, and radiation until reaching a desired state comprising a measureable change in at least one of reduction of an intraocular pressure of the eye, an increase of a vascular circulation of a peripapillary vessel of the eye, and an increase of a metabolic rate of one or more groups of cells of the eye.
  2. The device according to claim 1, wherein the goggle carrier is covering a periocular region of the eye.
  3. The device according to claim 1, wherein the eye is a first eye and the goggle carrier is covering the periocular region the first eye and also covering a periocular region of a second eye.
  4. The device according to claim 1, wherein the heat pad module comprises a heating element layer, a thermal insulation layer, and a soft contact layer.
  5. The device according to claim 4, wherein the heating element layer consists of a resistive heating strip embedded in a flexible printed circuit.
  6. The device according to claim 5, wherein the resistive heating strip embedded in the flexible printed circuit is powered by a pulse width modulated input voltage regulated by the controller.
  7. The device according to claim 6, wherein the thermal insulation layer is in contact with a first side of the heating element layer.
  8. The device according to claim 7, wherein the thermal insulation layer comprises a flexible material that conforms to a curved surface on or around the eye.
  9. The device according to claim 8, wherein the soft contact layer is in contact with a second side of the heating element layer.
  10. The device according to claim 9, wherein the soft contact layer is configured and adapted for contact with a layer of skin on an eyelid covering the eye.
  11. The device according to claim 2, wherein the pressure control module comprises a pump.
  12. The device according to claim 11, wherein the pressure control module comprises a first cannula fluidly coupling the pump to a cavity of the goggle carrier adjacent the periocular region.
  13. The device according to claim 12, wherein the pressure control module comprises a second cannula fluidly coupling the cavity to an area of ambient pressure.
  14. The device according to claim 13, wherein the second cannula comprises a check valve configured and adapted to allow fluid flow from the area of ambient pressure into the cavity while inhibiting fluid flow from the cavity into the area of ambient pressure.
  15. The device according to claim 14, wherein the check valve is configured and adapted to open when the gauge pressure in the cavity drops below a threshold pressure.

Description

TECHNICAL FIELD The present disclosure belongs to the technical field of treatment of condition, and specifically relates to a device for improving a state of an eye in a subject and to reduce the risk of suffering from glaucoma. BACKGROUND Glaucoma is an eye disease associated with damage to the optic nerve that can lead to vision loss. The risk of glaucoma increases with age and is related to ethnic or family history. However, there is no authorized preventive measure for patients in high-risk groups. High-risk individuals must rely upon regular eye exams, and treatments can only be started after diagnosis. Damage to the optic nerve can be caused by excessive intraocular pressure (IOP), resulting in over critical loading stresses in the optic nerve tissues. Lowering the ocular stresses is a crucial approach to slow down glaucoma progression and to inhibit glaucoma from developing in high-risk groups. The ocular stresses are associated with the biomechanical properties of the ocular tissue. The biomechanical property of the ocular tissue is an individual factor and is known to be related to aging. Ocular tissues with higher compliance are desired. High compliance tissues can have higher non-damaging deformation when response to gradual loading from IOP and result in lower accumulation of stresses. The regulation of the aqueous humor is also essential for IOP control. IOP is primarily controlled by the formation and the drainage of aqueous humor inside an eyeball. The drainage system of an eye is associated with the venous system connected to the Schlemm's canal. Maintaining a healthy condition of the blood circulation and the tissues supporting drainage is essential to inhibit aqueous humor accumulation that can lead to significant elevation of IOP. High IOP is not an inevitable feature of developing glaucoma. The biomechanical strength of the tissue associated to the optic nerve is also important to resist the damage. The exact mechanisms of deterioration and damage of the ocular tissues are unknown. But the poor vascular circulation of the peripapillary vessel and ineffective tissue cell metabolism are believed to be factors that affect the health of the optic nerve. Related art technologies have not fully addressed the above concerns. United States Patent 6,364,875 to Stanley, III teaches the combined effect of elevated temperature and stretching forces lead to permanent residual strains, reshaping the cornea. United States Patent 10,881,550 to Tedford et al. teaches multi-wavelength low level light therapy wherein two or more doses of light are delivered in a coordinated fashion to influence a desired target cell functionality. United States Patent Application Publication 2022/0168136 to BADAWI et al. teaches a patch or strip affixed to the skin of the upper and/or lower eyelids to deliver heat to the one or more meibomian glands contained within the underlying skin for dry eye treatment. Medina (Eye (2017) 31, 1621-1627; doi:10.1038/eye.2017.123) teaches that Pneumatic Keratology can be used to alter the cornea by non-invasive means. A vacuum chamber with radial openings alters the collagen fibers in the stroma and flattens the cornea. Jang et al. (Sci. Adv. 2021; 7 : eabf7194 31 March 2021) teaches a soft, smart contact lens and a skin-attachable therapeutic device for wireless monitoring and therapy of chronic ocular surface inflammation (OSI). US 2020/360723A1 discloses an apparatus for improving a condition of an eye in a subject comprising a heat module configured and adapted to warm a cornea, a peripapillary sclera, or an extraocular muscle of the eye to a threshold value that is above a skin surface temperature of the subject; a pressure control module configured and adapted to stretch the cornea, the peripapillary sclera, or the extraocular muscle of the eye of the eye to an extent sufficient to measurably change a periocular pressure of the eye, or an intraocular pressure of the eye, or both; a radiation module configured and adapted to irradiate one or more tissues of an eye with an infra-red radiation; and a controller 16 operably connected to the heat pad module, the pressure control module, and the radiation module, the apparatus uses the simultaneous combination of heat and suction to permanently stretch some of the collagen fibrils within the cornea, resulting in a change in the shape of the cornea and thus the focus of the eye. SUMMARY Embodiments of the subject invention provide devices to improve the states of an eye and to reduce the risk of suffering from glaucoma. Damage to the optic nerve can be caused by excessive intraocular pressure (IOP), resulting in over critical loading stresses in the optic nerve tissues. Lowering the ocular stresses is a crucial approach to slow down glaucoma progression and to inhibit glaucoma from developing in high-risk groups. The ocular stresses are associated with the biomechanical properties of the ocular tissue. The biomechanical property of the