Ophthalmic treatment device, system, and method of use

• US 9,622,911 B2
• Filed: 03/12/2014
• Issued: 04/18/2017
• 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): ROANE, AARON F
• Application Number:
  US14/206,847
• Publication Number:
  US 20140194957A1
• Time in Patent Office: 1,133 Days
• Field of Search: 606 4
• 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 defining an optical axis, and providing at least one treatment light concentric to the optical axis, the treatment light being selected from the 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 the treatment light to provide discontinuous treatment light projection onto an eye for a selected treatment time comprising successive treatment light exposure periods separated by non-treatment periods, wherein the treatment light exposure periods and non-treatment periods are of equal duration; and

a photosensitizer for application to the eye to promote corneal cross-linking during UVA light exposure periods, the photosensitizer comprising a riboflavin solution containing iodide ion wherein the treatment light exposure periods and non-treatment periods of are 15 seconds.

2. The system of claim 1, wherein the processor has an input for operator selection of parameters and duration for the successive treatment light exposure periods on the cornea and/or sclera.

3. The system of claim 1, wherein the treatment light has a wavelength in the range from 350 to 400 nm.

4. The system of claim 1, wherein the treatment light has a wavelength in the range from 365 to 420 nm.

5. The system of claim 1, wherein the at least one processor is programmed to control the treatment light intensity during each treatment light exposure period to increase the treatment light intensity gradually to a maximum treatment light intensity at the start of each treatment light exposure period and to dim the treatment light intensity from the maximum treatment light intensity to a low level prior to the end of each treatment light exposure period.

6. The system of claim 1, further comprising an anti-startle light of visible colored light, wherein the at least one processor is programmed to direct the anti-startle light towards an eye of a patient under treatment during non-treatment periods between treatment light exposure periods and to switch off the anti-startle light during treatment light exposure periods.

7. The system of claim 1, wherein the at least one optical treatment head comprises a light source array having one light source, or a plurality of light sources.

8. The system of claim 1, further comprising an optical projection device configured to direct the at least one treatment light onto a portion of an eye.

9. The system of claim 1, wherein the at least one processor is programmed to apply the at least one treatment light onto an eye in a predetermined pattern.

10. The system of claim 1, wherein the light control device applies the at least one treatment light to an eye in a plurality of predetermined patterns.

11. The system of claim 1, further comprising a light modulating device which partially or entirely blocks or unblocks the light source, wherein the at least one processor is programmed to control the light modulating device to block and unblock all or part of the light source to provide the discontinuous treatment light projection on the eye.

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

13. The system of claim 12, wherein the pattern control device is part of a light mask.

14. The system of claim 1, further comprising an optical sensor device which provides sensor output data to the at least one processor, and the at least one processor is programmed to adjust the intensity of part or all of the light source according to sensor output data collected from the optical sensor device.

15. The system of claim 14, wherein the optical sensor device is an optical collection device.

16. The system of claim 14, wherein the sensor device comprises a photoluminescent monitoring module which measures the intensity of photoluminescent emissions from the eye.

17. The system of claim 1, further comprising an environmental monitoring module which monitors concentrations of photosensitizer, oxygen, or both in the eye.

18. The system of claim 1, further comprising a fixation light in the visible light spectrum upon which an eye is focused during treatment.

19. The system of claim 1, wherein the light source device comprises at least one single-wavelength light source.

20. The system of claim 1, wherein said at least one optical treatment head comprises first and second optical treatment heads each including projection optics and configured to project respective treatment light onto the right and left eyes at a working distance of from two to six inches from the optical treatment heads.

21. The system of claim 20, wherein the first optical treatment head and second optical treatment head are adjustably mounted for multi-directional adjustment of the position of the optical treatment head relative to the respective eyes.

22. The system of claim 20, further comprising an intensity adjustment module configured to independently adjust the intensity of the at least one treatment light projected by the first optical treatment head and second optical treatment head.

23. The system of claim 1, further comprising a positioning apparatus associated with the optical treatment head, the positioning device comprising first and second visible light sources of different colors which emit respective first and second visible light aiming beams of different colors at an angle to the optical axis of the optical treatment head which cross over one another on the optical axis at a predetermined working distance from the optical treatment head sufficient to allow access to the eye during treatment when the eye is positioned at the cross over position of the aiming beams.