# US 2014/0194957 A1 · Ophthalmic treatment device, system, and method of use

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- Number: US 2014/0194957 A1
- Document ID: US20140194957A1
- Status: Published application
- Kind: A1
- Application number: 14/206,847
- Filed: 2014-03-12
- Published: 2014-07-10
- Earliest claimed: 2010-09-30
- Assignees: CXL Ophthalmics, LLC
- Applicants: CXL Ophthalmics, LLC
- Inventors: Roy S. Rubinfeld; Sandy T. Feldman; Kevin E. Daly; Raymond A. Hartman
- Web page: https://patentgrep.com/patent/US20140194957A1

## CPC

- A61F 9/0079: {using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves}
- A61F 9/008: using laser
- 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}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 38/44: Oxidoreductases (1)
- A61K 41/0066: {Psoralene-activated UV-A photochemotherapy (PUVA-therapy), e.g. for treatment of psoriasis or eczema, extracorporeal photopheresis with psoralens or fucocoumarins}
- A61K 49/0015: {Phosphorescence}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61F 2009/00865: {Sclera}
- A61F 2009/00872: {Cornea}
- A61F 2009/00893: {Keratoconus}
- A61N 5/067: using laser light
- A61N 2005/0626: {Monitoring, verifying, controlling systems and methods}
- A61N 2005/0652: {Arrays of diodes}
- A61N 2005/0661: {ultraviolet}
- A61N 2005/0663: {Coloured light}
- A61N 2005/0667: {Filters}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 1

An ophthalmic treatment system, comprising:
a light source device;
at least one optical treatment head operatively coupled to the light source device, and providing at least one treatment light; and
a light control device, which controls operation of the light source to provide discontinuous treatment light projection onto an eye; and/or adjusts intensity of part or all of the light source, providing adjusted intensity treatment light projection onto an eye.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 2)

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

### Claim 5 (depends on 2)

The system of claim 2, wherein the treatment light has a wavelength in the range from 350 to 400 nm.

### Claim 6 (depends on 2)

The system of claim 2, wherein the treatment light has a wavelength in the range from 365 to 420 nm.

### Claim 7 (depends on 1)

The system of claim 1, wherein the treatment light is selected from the group consisting of UVA light, a mixture of UVA and blue light, and blue light.

### Claim 8 (depends on 1)

The system of claim 1, wherein the controller further comprises a control module for dimming the treatment light intensity to a low level prior to the end of each treatment light exposure period and prior to the next treatment light exposure period, and for increasing the treatment light intensity gradually to a maximum treatment light intensity at the start of each treatment light exposure period.

### Claim 9 (depends on 1)

The system of claim 1, further comprising an anti-startle light, wherein the control device is configured to direct the anti-startle light towards an eye of a patient under treatment between treatment light exposure periods and switch off the anti-startle light during treatment light exposure periods.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

The system of claim 1, wherein the light control device applies the at least one treatment light onto an eye in a predetermined pattern.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 1)

The system of claim 1, wherein the at least one treatment light promotes corneal or scleral collagen cross-linking.

### Claim 15 (depends on 1)

The system of claim 1, wherein the light control device comprises a light modulating device which partially or entirely blocks or unblocks the light source, providing the discontinuous treatment light projection on the eye.

### Claim 16 (depends on 15)

The system of claim 15, wherein the light modulating device is operatively connected to a controller which controls movement of the light modulating device.

### Claim 17 (depends on 15)

The system of claim 15, wherein the controller comprises a microprocessor for controlling the blocking or unblocking of part or all of the light source.

### Claim 18 (depends on 1)

The system of claim 1, further comprising an intensity control device which adjusts intensity of part or all of the light source, providing the adjusted intensity treatment light projection onto the eye.

### Claim 19 (depends on 1)

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

### Claim 20 (depends on 19)

The system of claim 19, wherein the pattern control device is part of a light mask.

### Claim 21 (depends on 1)

The system of claim 1, further comprising an optical sensor device, wherein the control of the discontinuous treatment light, or the adjusting of the intensity of part or all of the light source, is controlled or adjusted according to data collected from the optical sensor device.

### Claim 22 (depends on 21)

The system of claim 21, wherein the optical sensor device is an optical collection device.

### Claim 23 (depends on 21)

The system of claim 21, wherein the sensor device comprises a photoluminescent monitoring module which measures the intensity of photoluminescent emissions from the eye.

### Claim 24 (depends on 1)

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

### Claim 25 (depends on 1)

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

### Claim 26 (depends on 1)

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

### Claim 27 (depends on 1)

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.

### Claim 28 (depends on 27)

The system of claim 27, 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.

### Claim 29 (depends on 27)

The system of claim 27, 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.

### Claim 30 (depends on 1)

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

### Claim 31

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 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 optical treatment head, whereby the 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 at a selected cycle frequency.

### Claim 32 (depends on 31)

The method of claim 31, wherein the selected cycle frequency is between one second and 10 minutes.

### Claim 33 (depends on 31)

The method of claim 31, wherein the treatment light has a frequency in the range of 350 to 400 nm.

### Claim 34 (depends on 31)

The method of claim 31, further comprising adjusting the intensity of the at least one treatment light applied to the eye to gradually increase the intensity at the start of each treatment light exposure period and gradually decrease the intensity at the end of the treatment light exposure period.

### Claim 35 (depends on 31)

The method of claim 31, wherein providing discontinuous treatment light projection onto the eye comprises blocking and unblocking the at least one treatment light beam at predetermined time intervals to provide discontinuous light projection on the cornea and/or sclera.

### Claim 36 (depends on 31)

The method of claim 31, wherein providing discontinuous treatment light projection onto the eye comprises controlling the light source to produce a discontinuous treatment light output.

### Claim 37 (depends on 31)

The method of claim 31, further comprising controlling one or more parameters of the light spot on the patient's eye, the parameters comprising one or more of size, shape, pattern and intensity.

### Claim 38 (depends on 31)

The method of claim 31, further comprising directing an anti-startle light onto the eye between treatment light exposure periods.

### Claim 39 (depends on 31)

The method of claim 31, wherein the method further comprises contacting the eye with a photosensitizer.

### Claim 40 (depends on 38)

The method of claim 38, wherein the photosensitizer is riboflavin, rose Bengal, other photosensitizers, or derivatives thereof.

### Claim 41 (depends on 38)

The method of claim 38, further comprising monitoring the level of photoluminescent emissions from the eye during treatment and determining approximate photosensitizer concentration in the eye based on the level of photoluminescent emissions.

### Claim 42 (depends on 31)

The method of claim 31, further comprising positioning the optical treatment head at the predetermined working distance from the patient's eye prior to treatment, the step of positioning the optical treatment head comprising directing first and second aiming light beams from the optical treatment head, the aiming light beams intersecting at said predetermined working distance, and adjusting the position of the optical treatment head relative to the eye until a spot of light formed by the intersecting aiming light beams is located at a selected position on the patient's eye.

### Claim 43 (depends on 41)

The method of claim 41, wherein the first and second aiming light beams are of different colors, whereby a spot of light on the patient's eye changes color when the treatment beam outlet of the optical treatment head is positioned at the predetermined working distance and aligned with the selected treatment position on the eye.

### Claim 44 (depends on 31)

The method of claim 31, further comprising directing a second light beam of said predetermined wavelength band from a second light source along a predetermined light path from the light source to a treatment light outlet of a second optical treatment head, projecting the second light beam from the outlet of the optical treatment head towards the other eye of the patient, and controlling the second light beam to produce at least one light spot of predetermined size and shape on the other eye at the predetermined working distance from the optical treatment head, and controlling the light source or projected light beam to provide discontinuous treatment light projection onto the eye at a selected cycle frequency.

### Claim 45 (depends on 31)

The method of claim 31, wherein the light intensity is at a first level during each treatment light exposure period and at a second, lower level between successive treatment light exposure periods, and the intensity control device is configured to increase the treatment light intensity gradually from the second level to the first level at the start of each treatment light exposure period and to dim the treatment light gradually from the first level to the second level prior to the end of each treatment light exposure period.
