Ophthalmic treatment solution delivery devices and delivery augmentation methods

• US 10,575,986 B2
• Filed: 05/12/2014
• Issued: 03/03/2020
• Est. Priority Date: 03/29/2012
• Status: Active Grant

• Current Assignee: CXL Ophthalmics, LLC
• Original Assignee: CXL Ophthalmics, LLC
• Inventors: Rubinfeld, Roy S., Korteweg, Wayne
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Lee, Weng
• Application Number:
  US14/275,192
• Publication Number:
  US 20140249509A1
• Time in Patent Office: 2,122 Days
• Field of Search: None
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

A first sponge device for use to manipulate and prepare the surface of the epithelium of an eye prior to application of an ophthalmic solution has a handle and a sponge head secured to the handle. The head is made of an absorbent, wicking sponge material and has a non-sharp, tissue preparation surface of predetermined shape for rubbing across the surface of the epithelium layer in order to manipulate the tissue. After the surface is prepared, a second, holding sponge is placed over the eye to act as a reservoir and to hold ophthalmic solution against the eye surface.

Claims

1. A sponge device for use in preparation of the epithelium of an eye prior to application of an ophthalmic solution, comprising:

a handle having an end portion; and

a head secured to the end portion of the handle, the head being formed entirely from a single absorbent, fast wicking sponge material;

wherein the head is configured to expand from a first configuration having a circular disk shape or part circular disk shape with opposite flat surfaces when dry to a second configuration different from the first configuration and having a spherical or part spherical shape when wetted, at least the second configuration having no sharp edges and comprising an epithelial tissue preparation surface configured for rubbing across the surface of an eye.

2. The device of claim 1, wherein the head has a peripheral rim of at least part circular shape in the first configuration, and the end portion of the handle is exposed in the first configuration and enclosed by the expanded, spherical or part spherical head in the second configuration.

3. The device of claim 2, wherein the peripheral rim of the head has a part-circular portion and a straight rim portion facing away from the part-circular portion in a dry condition, and the end portion of the handle is secured at the center of the straight rim portion and has spaced gripping portions defining a recess in which a central portion of the head is engaged, whereby the end portion grips and restricts the central portion of the head from expanding when the head is wetted.

4. The device of claim 3, wherein the part-circular portion of the rim is at least a semi-circle.

5. The device of claim 4, wherein the part-circular portion is greater than a semi-circle.

6. The device of claim 2, wherein the peripheral rim is of circular shape.

7. The device of claim 2, wherein the thickness of the head in the dry condition is in the range from about 0.5 mm. to about 3 mm.

8. The device of claim 7, wherein the thickness of the head in the dry condition is about 1 mm.

9. The device of claim 2, wherein the diameter of the head is in the range from about 4.5 mm. to about 8 mm.

10. The device of claim 1, wherein the sponge material comprises cellulose or polyvinyl acetate.

11. The device of claim 10, wherein the pore size of the sponge material is in the range from 60 to 120 microns.

12. The device of claim 11, wherein the pore size is about 60 microns.

13. A delivery system for delivery of ophthalmic solutions to the eye, comprising:

a first, eye surface preparation sponge device comprising a handle and a head secured to the handle, wherein the head is formed entirely from a single absorbent, fast-wicking sponge material and is configured to expand from a first configuration having a first shape and dimensions when dry into a second configuration having a second shape and dimensions different from the first configuration when wetted, at least the second configuration being generally rounded with no sharp edges and comprising an epithelial tissue preparation surface of predetermined shape configured for rubbing across the surface of the epithelium of an eye to prepare the surface for penetration by ophthalmic solutions; and

a second, loading sponge device of absorbent, fast-wicking sponge material comprising a disk-shaped sponge having a continuous circular periphery with no indents, opposite flat faces and no opening, a predetermined diameter and a thickness less than the diameter, wherein the disk-shaped sponge has increased flexibility when wetted and loaded with an ophthalmic solution and is configured to cover at least the corneal portion of the eye with no portion of the underlying cornea exposed and to adopt the curvature of the underlying eye surface when wetted with the ophthalmic solution and centrally placed over the eye for loading of ophthalmic solution into the eye after preparation of the eye surface with the first sponge device.

14. The delivery system of claim 13, wherein at least one of the sponges is pre-wetted with an ophthalmic solution.

15. The delivery system of claim 14, wherein the loading sponge device is pre-wetted with an ophthalmic solution.

16. The delivery system of claim 13, wherein the sponge material of the first sponge device and the second sponge device is cellulose or polyvinyl acetate sponge material.

17. The delivery system of claim 13, wherein the thickness of the head of the first sponge device in the first configuration is in the range from about 0.5 mm. to about 3 mm.

18. The delivery system of claim 17, wherein the thickness of the second, disk-shaped sponge device is about the same as the thickness of the head of the first sponge device.

19. The delivery system of claim 13, wherein the circular, disk-shaped sponge has a diameter in the range from about 3 mm to about 12 mm.

20. The delivery system of claim 19, wherein the diameter of the circular, disk-shaped sponge is in the range from about 8 mm to about 12 mm.

21. The delivery system of claim 13, wherein the head of the first sponge device has opposite flat surfaces and a peripheral rim of at least part circular shape, the handle has an end portion secured to a central portion of the head in the first configuration and the head is configured to expand into a substantially ball-like shape enclosing the end portion of the handle in the second configuration.

22. The delivery system of claim 21, wherein the peripheral rim of the head has a part-circular rim portion and a straight rim portion facing away from the part-circular portion in the first configuration, and the end portion of the handle is secured at the center of the straight rim portion and engages the opposite flat surfaces of a central portion of the head in the first configuration, whereby the end portion grips and restricts the central portion of the head from expanding when the head is wetted.

23. The delivery system of claim 22, wherein the part-circular portion of the rim extends around an arc comprising at least a semi-circle.

24. The delivery system of claim 22, wherein the part-circular portion extends around an arc greater than a semi-circle.

25. The delivery system of claim 21, wherein the peripheral rim is of circular shape.

26. The delivery system of claim 13, wherein the head of the first sponge device is of spherical or part spherical shape in the second configuration.

27. The delivery system of claim 13, wherein the sponge material of both sponges has a pore size in the range from about 60 microns to about 1000 microns.

28. The delivery system of claim 27, wherein the pore size of the sponge material of both sponges is in the range from about 60 microns to about 120 microns.

29. The delivery system of claim 28, wherein the pore size is about 60 microns.