Ocular cross-linking system and method for sealing corneal wounds

• US 9,555,111 B2
• Filed: 03/27/2013
• Issued: 01/31/2017
• Est. Priority Date: 03/29/2012
• Status: Active Grant

• Current Assignee: CXL Ophthalmics, LLC
• Original Assignee: CXL Ophthalmics, LLC
• Inventors: Rubinfeld, Roy S., Hartman, Raymond A., Feldman, Sandy T.
• Primary Examiner(s): Crandall, Lynsey
• Assistant Examiner(s): Xie, Dacheng
• Application Number:
  US14/387,532
• Publication Number:
  US 20150126921A1
• Time in Patent Office: 1,406 Days
• Field of Search: 606/4, 424/9.6, 424/94.4, 424/671
• US Class Current: 1/1
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61F 2009/00865 Sclera
• CPC Class Codes: A61F 2009/00872 Cornea
• 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: 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 33/18 Iodine; Compounds thereof
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• CPC Class Codes: A61K 41/0057 Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61N 2005/0626 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 2005/0662 Visible light
• 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
• CPC Class Codes: C12Y 111/01006 : Catalase (1.11.1.6)

Abstract

Wounds in the eye following surgery or injury are sealed by soaking the area with a riboflavin solution containing iodide ion and irradiating the wound area with UVA radiation in a selected wavelength range for a selected time period to promote cross-linking of tissue between opposite surfaces of the wound or between the incised wound surfaces and a graft or implant.

Claims

1. A corneal collagen cross-linking system, the system comprising:

(a) a supply of a photosensitizer solution that promotes photochemical cross-linking in eye tissue, the photosensitizer solution comprising a hypotonic or aqueous solution containing

(i) 0.5 wt. % riboflavin, and

(ii) 0.015 wt. % to 5 wt. % sodium iodide, wherein the iodide is in ionized (I⁻

) form and the solution maintains a basic pH that permits iodide ion to catalytically break hydrogen peroxide into water and oxygen; and

(b) a light source having an output in a selected UVA or UVA/blue or blue light range.

2. The corneal collagen cross-linking system of claim 1, further comprising an adjustable optical treatment head, the treatment head comprising an optical projector defining an optical axis and configured to project a beam of light in a predetermined UVA or UVA/blue or blue light range along the optical axis.

3. The corneal collagen cross-linking system of claim 1, further comprising a positioning control element for adjusting distance from the eye and the orientation of the optical axis relative to an axis of the eye.

4. The corneal collagen cross-linking of claim 1, further comprising a beam intensity adjustment module for adjusting the light intensity incident on the eye.

5. The corneal collagen cross-linking system of claim 1, further comprising a control module that controls a treatment time period.

6. The corneal collagen cross-linking system of claim 2, wherein the adjustable optical treatment head is adjustable in at least one of an x-axis, a y-axis, and a z-axis.

7. The corneal collagen cross-linking system of claim 1, wherein the UVA or UVA/blue radiation is in a wavelength range from 320 nm to 500 nm.

8. The corneal collagen cross-linking system of claim 1, wherein the UVA radiation is in a wavelength range from 330 nm to 380 nm.

9. The corneal collagen cross-linking system of claim 1, wherein the UVA/blue radiation is in a wavelength range from 400 to 470 nm.

10. The corneal collagen cross-linking system of claim 1, wherein the UVA or UVA/blue radiation is in a wavelength range from 400 to 410 nm.

11. The corneal collagen cross-linking system of claim 1, wherein the basic pH is between 7 and 8.4, not including 7.

12. A corneal collagen cross-linking system, the system comprising:

(a) a supply of a photosensitizer solution that promotes photochemical cross-linking in eye tissue, the photosensitizer solution comprising a hypotonic or aqueous solution containing

(i) 0.5 wt. % riboflavin, and

(ii) 0.015 wt. % sodium iodide, wherein the iodide is in ionized (I⁻

) form and the solution maintains a basic pH that permits iodide ion to catalytically break hydrogen peroxide into water and oxygen; and

(b) a light source having an output in a selected UVA or UVA/blue or blue light range.