Ophthalmic treatment device, system, and method of use

• US 10,285,857 B2
• Filed: 09/21/2016
• Issued: 05/14/2019
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: CXL Ophthalmics, LLC
• Original Assignee: CXL Ophthalmics, LLC
• Inventors: Rubinfeld, Roy S., Feldman, Sandy T., Daly, Kevin E., Hartman, Raymond A.
• Primary Examiner(s): Nganga, Boniface
• Application Number:
  US15/271,668
• Publication Number:
  US 20170065826A1
• Time in Patent Office: 965 Days
• CPC Class Codes: A61F 2009/00865 Sclera
• 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 9/013 Instruments for compensation of ocular refraction A61F9/008 takes precedence; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: A61K 41/0066 Psoralene-activated UV-A photochemotherapy (PUVA-therapy), e.g. for treatment of psoriasis or eczema, extracorporeal photopheresis with psoralens or fucocoumarins
• CPC Class Codes: A61K 49/0015 Phosphorescence
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61N 2005/0626 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 2005/0663 Coloured light
• CPC Class Codes: A61N 2005/0667 Filters
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/067 using laser light

Abstract

Ophthalmic treatment systems and methods of using the systems are disclosed. The ophthalmic treatment systems include (a) a light source device; (b) at least one optical treatment head operatively coupled to the light source device, comprising a light source array, and providing at least one treatment light; and (c) a light control device, which (i) provides patterned or discontinuous treatment light projection onto an eye (e.g., the cornea and/or sclera of an eye); or (ii) adjusts intensity of part or all of the light source array, providing adjusted intensity treatment light projection onto an eye (e.g., the cornea and/or sclera of an eye). The at least one treatment light promotes corneal and/or scleral collagen cross-linking.

Claims

1. An ophthalmic treatment system, comprising:

a light source device;

at least one optical treatment head operatively coupled to the light source device, and configured to provide at least one treatment light and an anti-startle light of visible colored light from the light source device, the treatment light being selected from group consisting of UVA light, blue light, and a mixture of UVA and blue light;

at least one processor associated with the light source device and programmed to control operation of the light source device to provide discontinuous treatment light projection onto an eye of a patient under treatment for a selected treatment time comprising successive treatment light exposure periods of a first light intensity level separated by non-treatment periods at a second light intensity level lower than the first light intensity level and to switch on the anti-startle light to be directed towards the eye of the patient during the non-treatment periods and switch off the anti-startle light during treatment light exposure periods.

2. The system of claim 1, wherein the at least one processor is programmed to control operation of the light source device to provide discontinuous treatment light projection from the optical treatment head onto a cornea and/or sclera of the eye at a treatment light exposure period of between one second and 10 minutes.

3. The system of claim 2, wherein the at least one processor has an input for operator selection of parameters and duration for the discontinuous light projection on the cornea and/or sclera.

4. The system of claim 2, wherein each treatment light exposure period and non-treatment period of the discontinuous treatment light projection is of equal duration and in the range from 5 seconds to 25 seconds.

5. The system of claim 1, wherein the at least one processor further comprises an intensity control module for gradually decreasing and increasing an intensity of the discontinuous treatment light projection between the first light intensity and the second light intensity.

6. The system of claim 1, further comprising a pattern control device which provides patterned treatment light projection onto the eye.

7. The system of claim 6, wherein the pattern control device is part of a light mask.

8. The system of claim 1, further comprising an optical sensor device having an output in communication with the at least one processor, wherein the at least one processor further comprises a treatment light control module which adjusts the intensity of part or all of the light source according to data collected from the optical sensor device.

9. The system of claim 1, further comprising a fixation light upon which an eye is focused during treatment.

10. The system of claim 1, wherein the selected treatment time is in the range from twenty to thirty minutes.

11. The system of claim 5, wherein the first light intensity level is between 3-4 mW/cm² and wherein the second light intensity is between 0.1 to 0.2 mW/cm².

12. The system of claim 1, wherein each treatment light exposure period and non treatment period has a duration of 15 seconds.

19. The system of claim 5, wherein the first light intensity is between 3-4 mW/cm², and wherein the second light intensity is 0 mW/cm².

20. The system of claim 19, wherein the first light intensity level is 4 mW/cm².

13. A method of producing a treatment light for use in phototherapy treatment of an eye, comprising:

directing at least one light beam of at least one predetermined wavelength band from a light source along a predetermined light path from the light source to an outlet of at least one optical treatment head;

projecting the light beam from the outlet of the at least one optical treatment head towards one eye of a patient and focusing the beam to produce at least one light spot of predetermined size and shape on the eye at a predetermined working distance from the at least one optical treatment head, whereby the at least one optical treatment head is positioned at a distance from the eye sufficient to allow access to the eye; and

controlling the light source or projected light beam to provide discontinuous treatment light projection onto the eye for a selected treatment time, the discontinuous treatment light projection comprising successive treatment light exposure periods of a first light intensity level separated by non-treatment periods at a second light intensity level lower than the first light intensity level, wherein the discontinuous treatment light is selected from a group consisting of UVA light, blue light, and a mixture of UVA and blue light; and

projecting an anti-startle light of visible colored light from a second light source to be directed towards the eye during the non-treatment periods.

14. The method of claim 13, wherein the selected treatment time is between one second and 10 minutes.

15. The method of claim 13, wherein providing discontinuous treatment light projection onto the eye comprises controlling the light source with at least one processor to produce discontinuous treatment light projection.

16. The method of claim 13, further comprising increasing the treatment light intensity gradually from the second light intensity level to the first light intensity level at the start of each treatment light exposure period and to dim the treatment light gradually from the first light intensity level to the second light intensity level prior to the end of each treatment light exposure period.

17. The method of claim 13, further comprising wiping the surface of the eye with a sponge to disrupt the epithelium, and applying a riboflavin photosensitizer solution to the epithelium to penetrate through the epithelium into the corneal stroma before projecting the light beam onto the eye.

18. An ophthalmic treatment system, comprising:

a light source device;

first and second optical treatment heads operatively coupled to the light source device, and configured to provide at least one treatment light, the treatment light being selected from group consisting of UVA light, blue light, and a mixture of UVA and blue light;

at least one processor associated with the light source device and programmed to control operation of the light source device to provide discontinuous treatment light projection onto an eye for a selected treatment time comprising successive treatment light exposure periods of a first light intensity level separated by non-treatment periods at a second light intensity level lower than the first light intensity level; and

a height adjustable support stand, a first adjustable arm including a flexible, adjustable gooseneck supporting the first optical treatment head on the support stand and a second adjustable arm including a flexible, adjustable gooseneck supporting the second optical treatment head on the support stand, each optical treatment head comprising a housing having a lower surface including a UVA/blue light output port and first and second positioning light output ports on opposite sides of the UVA/blue lightoutput port, the first and second positioning light output ports configured to emit angled light beams of two different colors which cross over at the predetermined working distance from the treatment head in alignment with the UVA/blue light output port.