Formulations, devices, and methods for alleviating symptoms of ocular surface discomfort
Inventors
Sidoti, Charles • STRYJEWSKI, Tomasz • STEFATER, James • Kagan, Olivier • Sabir, Sameer • LI, Katelyn • Brucato, Danielle • AARON, Joseph
Assignees
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Publication Number
US-12667482-B2
Publication Date
2026-06-30
Expiration Date
Abstract
Disclosed herein are cold slurry formulations, devices, and methods for alleviating symptoms of ocular surface discomfort. Cold slurry formulations comprising ice, a freezing temperature depressant, and, optionally, a lipid are disclosed. Devices and methods for protecting a target ocular surface from contacting a cold slurry formulation that is used to maintain the target ocular surface at a temperature desired for alleviating symptoms of ocular surface discomfort are disclosed. Self-contained devices configured to receive a cold slurry formulation for maintaining the target ocular surface at a temperature desired for alleviating symptoms of ocular surface discomfort are disclosed. Devices and methods are disclosed for protecting a cornea and/or eyelid of a subject from the freezing cold slurry formulation that is directly or indirectly applied or injected into the target ocular surface. Kits comprising multiple syringes for administering multiple doses of the cold slurry to the target ocular surface, are disclosed.
Core Innovation
The invention relates to cold slurry formulations comprising ice crystals in a water-based carrier, optionally with a freezing-point depressant and optionally with a lipid such as soy-Phosphatidylcholine. The formulation is used to support ocular hypesthesia or hypoesthesia for ocular surface discomfort by lowering the temperature of an ocular surface while using a thermal contact structure that targets heat transfer to the cold slurry.
The invention further provides self-contained cooling device concepts that cool a target tissue surface of an ocular surface by conducting heat from the target tissue surface into a sealed formulation chamber holding the cold slurry or a formulation that is frozen to a subzero temperature. The target surface interface is configured to contact or interface with the ocular surface while maintaining substantially the same outer dimensions before contacting the target tissue surface, during treatment, and after removal.
The disclosure describes interface configurations to mitigate undesired direct corneal or eyelid freezing/irritation, including cornea-protecting suction/insulating concepts and eyelid-protecting spacer concepts, and an ocular surface interface supported by thermally conductive and/or low-adhesion surface features. It also includes device structures that incorporate a lid configured to fit over and seal a formulation chamber, and in other embodiments a housing and a heat exchanger with an aperture configured to allow clinician visualization of a cornea.
Documented characterization in the disclosure includes temperature drop kinetics in pig-eye profiling and sustained hypesthesia measurements, including evaluation of corneal healing after abrasion and reported absence of observed permanent corneal damage. The disclosed device ecosystem further includes kit concepts for multiple cold slurry doses with thermal and moisture protection features.
Claims Coverage
The partial content contains three independent claims (clm-00001, clm-00012, and clm-00028). Across these claims, the inventive coverage centers on self-contained ocular cooling devices using a formulation chamber with ice crystals or frozen formulation and a target surface interface that conducts heat from the ocular tissue to the cold formulation, optionally including sealing, corneal visualization via an aperture, and an interface arrangement that maintains substantially constant outer dimensions or specific adherence behavior.
Self-contained ocular cooling with sealed chamber and dimension-stable interface
A self-contained cooling device comprising a formulation chamber with an open end configured to receive and hold a cold slurry formulation having a plurality of ice crystals; a lid configured to fit over and seal the open end; and a target surface interface with a first surface configured to contact the target tissue surface and a second surface contained within the formulation chamber, wherein the target surface interface conducts heat from the target tissue surface to the cold slurry formulation, and the outer dimensions of the first surface remain substantially the same before contacting the target tissue surface, during treatment, and after removal.
Self-contained ocular cooling via frozen formulation in a heat exchanger with cornea visualization aperture
A self-contained cooling device comprising a housing; a heat exchanger with a formulation chamber configured to receive and hold a formulation configured to freeze to a subzero temperature in a cold environment; an aperture configured to allow a clinician to visualize a cornea; and a target surface interface with a first surface configured to contact the target tissue surface and a second surface contained within the formulation chamber, wherein the target surface interface conducts heat from the target tissue surface to the formulation after the formulation has been frozen to a subzero temperature within the formulation chamber.
Method of alleviating ocular surface discomfort by contact cooling with a self-contained freezing formulation device
A method of alleviating symptoms of ocular surface discomfort comprising cooling a self-contained cooling device containing a formulation configured to at least partially freeze when cooled; placing the self-contained cooling device in contact with a target ocular surface; allowing the self-contained cooling device to lower the temperature of the target ocular surface for a period of time sufficient to alleviate symptoms of ocular surface discomfort; wherein the self-contained cooling device comprises a housing, a heat exchanger with a formulation chamber receiving and holding the formulation, an aperture allowing clinician visualization of a cornea, and a target surface interface with a first surface configured to contact the target ocular surface and a second surface configured to be contained within the formulation chamber.
The independent claims consistently require self-contained cooling of an ocular surface using a formulation that is chilled to freeze or is held as a cold slurry with ice crystals and a target surface interface arranged to conduct heat from the ocular tissue to the cold formulation. Claim coverage further differentiates embodiments by including a sealed formulation chamber with a lid and dimension-stable contacting surface, or by using a heat exchanger with clinician visualization via an aperture, and includes a method claim for alleviating ocular surface discomfort by sustained contact cooling with the self-contained device.
Stated Advantages
Alleviates symptoms of ocular surface discomfort by lowering the temperature of the target ocular surface for a period of time sufficient to alleviate symptoms.
Reduces discomfort on the ocular surface by keeping the eye surface at a suitable temperature.
Reported absence of observed permanent corneal damage.
Documented Applications
Cooling a target ocular surface of a subject to support ocular hypesthesia/hypoesthesia for ocular surface discomfort, including during or after ocular surface discomfort symptom alleviation using a self-contained cooling device.
Alleviating symptoms of ocular surface discomfort by cooling a self-contained cooling device containing a formulation configured to at least partially freeze and placing the device in contact with a target ocular surface.
Evaluation of corneal healing after abrasion.
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