Apparatus for the treatment and/or prevention of corneal diseases

• US 10,182,941 B2
• Filed: 04/23/2012
• Issued: 01/22/2019
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Farhad Hafezi, Olivier Richoz
• Original Assignee: Farhad Hafezi
• Inventors: Hafezi, Farhad, Richoz, Olivier
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US14/114,356
• Publication Number:
  US 20140114232A1
• Time in Patent Office: 2,465 Days
• Field of Search: 604 20, 604501
• CPC Class Codes: A61F 2009/00872 Cornea
• CPC Class Codes: A61F 2009/00893 Keratoconus
• CPC Class Codes: A61F 9/0079 using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/009 Auxiliary devices making contact with the eyeball and coupling in laser light, e.g. goniolenses apparatus for eye examination A61B3/0008
• CPC Class Codes: A61N 2005/0643 Applicators, probes irradiating specific body areas in close proximity
• CPC Class Codes: A61N 2005/0651 Diodes
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 5/06 using light
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

An apparatus for the treatment and/or prevention of corneal diseases includes an applicator head. The applicator head includes a radiation source capable of exciting a non-toxic chromophore. A control is operable to activate the radiation source to radiate, wherein at least one of the following two conditions is met: the applicator head includes a sensor capable of measuring a signal dependent on a position of the applicator head relative to the cornea; or, the applicator head is configured to be in physical contact with the cornea. The control is operable to activate the radiation source to radiate depending on a signal measured by the sensor or to activate the radiation source when the applicator head touches the cornea, respectively.

Claims

1. An apparatus for the treatment and/or prevention of corneal diseases, the apparatus comprising:

an applicator head, the applicator head comprising a radiation source configured to emit a first radiation capable of exciting a non-toxic therapeutic substance applied to a cornea; and

a control operable to activate the radiation source to radiate the first radiation;

wherein the applicator head further comprises a fluorescence sensor configured to obtain a measurement result by measuring a fluorescent radiation emitted by the non-toxic therapeutic substance upon irradiation by the first radiation, the fluorescent radiation having a spectral composition different from a spectral composition of the first radiation,

wherein the control is configured to use the measurement result from the fluorescence sensor;

to evaluate whether the applicator head is within a predetermined distance from the cornea,

to evaluate whether a predetermined amount of the non-toxic therapeutic substance is present on the cornea, and

to activate the radiation source to further radiate only when the measurement result indicates that the applicator head is within the predetermined distance from the cornea and that the predetermined amount of the non-toxic therapeutic substance is present on the cornea.

2. The apparatus according to claim 1, the applicator head further comprising a proximity sensor sensing whether the applicator head makes contact with the cornea.

3. The apparatus according to claim 1, wherein the applicator head is equipped for enabling a visual control of a physical contact between the applicator head and the cornea.

4. The apparatus according to claim 1, wherein the applicator head is configured to be a single-use component.

5. The apparatus according to claim 1, wherein the applicator head comprises a connector for a plug-and socket connection to a control unit, a computer and/or a power source.

6. The apparatus according claim 1, wherein the radiation source comprises or is connected to a single LED or a plurality of LEDs as radiation generating means.

7. The apparatus according to claim 1, wherein the radiation source is configured to radiate at powers between 0.5 mW and 25 mW.

8. The apparatus according to claim 1, wherein the radiation source comprises at least one fiber optic cable that connects a distal portion of the applicator head with a radiation generating element placed outside of the applicator head.

9. The apparatus according to claim 1, wherein the applicator head further comprises a camera placed to monitor the cornea during treatment.

10. The apparatus according to claim 1, further comprising an at least partially transparent, exchangeable outer cover shaped to be placed to partially encase an applicator head housing.

11. The apparatus according to claim 10, further comprises an optical lens.

12. The apparatus according to claim 1, wherein the applicator head is shaped to cooperate with a mount of a standard Goldmann applanation tonometer used in slit lamps.

13. The apparatus according to claim 12, wherein the applicator head has a housing with a cylindrical proximal portion.

14. The apparatus according to claim 1, wherein the radiation emitted by the radiation source is radiation with a specific wavelength between 280 and 1300 nm, dependent on an absorption spectrum of a photoactive therapeutic agent being the non-toxic therapeutic substance.

15. The apparatus according to claim 14, wherein the apparatus is configured to excite Riboflavin as the non-toxic therapeutic substance and wherein the emission spectrum of the radiation source has a substantial power spectral density at 365 nm wavelength.

16. An applicator head for an apparatus for the treatment and/or prevention of corneal diseases, the applicator head comprising:

a radiation source capable of emitting a first radiation that excites a non-toxic therapeutic substance applied to a cornea;

a fluorescence sensor configured to obtain a measurement result by measuring a fluorescent radiation emitted by the non-toxic therapeutic substance upon irradiation by the first radiation, the fluorescent radiation having a spectral composition different from a spectral composition of the first radiation; and

a control or a connector to a control;

wherein the control is configured to use the measurement result from the fluorescence sensor;

to evaluate whether the applicator head is within a predetermined distance from the cornea,

to evaluate whether a predetermined amount of the non-toxic therapeutic substance is present on the cornea, and

to activate the radiation source to further radiate only when the measurement result indicates that the applicator head is within the predetermined distance from the cornea and that the predetermined amount of the non-toxic therapeutic substance is present on the cornea.

17. A kit of parts comprising an applicator head according to claim 16, further comprising a dose of a photoactive therapeutic agent as the non-toxic therapeutic substance.

18. A control unit of an apparatus for the treatment and/or prevention of corneal diseases, the control unit comprising

an interface to an applicator head,

a radiation source configured to emit a first radiation, and

a fluorescence sensor configured to obtain a measurement result by measuring a fluorescent radiation emitted, upon irradiation by the first radiation, by a non-toxic therapeutic substance applied to the cornea, the fluorescent radiation having a spectral composition different from a spectral composition of the first radiation,

wherein the control unit is configured to use the measurement result from the fluorescence sensor:

to evaluate whether the applicator head is within a predetermined distance from the cornea;

to evaluate whether a predetermined amount of the non-toxic therapeutic substance is present on the cornea, and

to activate the radiation source to further radiate only when the measurement result indicates that the applicator head is within the predetermined distance from the cornea and that the predetermined amount of the non-toxic therapeutic substance is present on the cornea.

19. A method of treating and/or preventing a corneal disease, the method comprising the steps of:

applying a therapeutic amount of a photoactive therapeutic agent to a cornea;

providing an apparatus with an applicator head, the applicator head comprising a radiation source configured to emit a first radiation capable of exciting a chromophore of the photoactive therapeutic agent and activating the photoactive therapeutic agent;

positioning the applicator head near the cornea;

obtaining a measurement result by measuring, with a fluorescence sensor, a fluorescent radiation of a spectral composition different from a spectral composition of the first radiation, the fluorescent radiation emitted by the chromophore upon irradiation by the first radiation,

using the measurement result from the fluorescence sensor to evaluate whether a condition is met that;

the applicator head is within a predetermined distance from the cornea, and

a predetermined amount of the chromophore is present on the cornea; and

in case the condition is met, further irradiating the cornea by the radiation source and thereby activating the photoactive therapeutic agent.