Scleral prosthesis for treating presbyopia and other eye disorders and related devices and methods

• US 8,409,277 B2
• Filed: 07/11/2007
• Issued: 04/02/2013
• Est. Priority Date: 07/11/2006
• Status: Active Grant

• Current Assignee: Refocus Group Incorporated
• Original Assignee: ReFocus Ocular, Inc.
• Inventors: Griffis, Jack C. III, Cox, Mark A., Williamson, Douglas C., Richardson, Peter J., Soloway, Barrie D., Bare, Rex O., Scherer, Andrew J., Payne, Timothy J., Zdenek, Gene W., Smolek, Michael K.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US11/827,382
• Publication Number:
  US 20080091266A1
• Time in Patent Office: 2,092 Days
• Field of Search: 623/4.1, 623/6.12, 604/8
• US Class Current: 623/4.1
• CPC Class Codes: A61F 2/147 Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• CPC Class Codes: A61F 2/148 Implantation instruments specially adapted therefor
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Abstract

One example scleral prosthesis includes a first free end and a second free end, each wider than a middle portion of the scleral prosthesis. Multiple first portions form the first end of the scleral prosthesis. The first portions are separated along at least half of a length of the scleral prosthesis. Multiple second portions may form the second end of the scleral prosthesis, and the second portions may be separated along less than a quarter of the length of the scleral prosthesis. An implantation device can be used to facilitate implantation of a scleral prosthesis. The implantation device includes a first end portion configured to be inserted into a scleral tunnel of an eye. The implantation device also includes a second end portion configured to receive the scleral prosthesis. A rod with a tapered and rounded end can be partially inserted into the first end portion of the implantation device.

Claims

1. A scleral prosthesis comprising:

an elongated body having a first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body;

wherein the body comprises multiple first portions that form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along at least half of a total length of the body from the first free end to the second free end by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

wherein the body further comprises multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space;

wherein the first portions of the body are biased to maintain separation from one another without external interference but are configured to be pushed towards each other to reduce the width of the first end so that the second end is wider than a remainder of the body; and

wherein the scleral prosthesis is configured to be implanted into scleral tissue of an eye.

2. The scleral prosthesis of claim 1, wherein:

the first portions run substantially parallel to one another along the length of the body; and

the second portions run substantially parallel to one another along the length of the body.

3. The scleral prosthesis of claim 1, wherein the second portions are separated along less than a quarter of the length of the body.

4. The scleral prosthesis of claim 1, wherein the first and second ends comprise areas that project from the first and second sides of the body to make the first and second ends wider than the body between the ends.

5. The scleral prosthesis of claim 4, wherein the areas that project from the sides of the body at the first end comprise hook-shaped areas.

6. The scleral prosthesis of claim 5, wherein the hook-shaped areas at the first end of the body are hooked towards the second end of the body.

7. The scleral prosthesis of claim 4, wherein the areas that project from the sides of the body are generally cylindrical with flat bottoms.

8. The scleral prosthesis of claim 4, wherein the areas that project from the sides of the body are generally triangular.

9. The scleral prosthesis of claim 1, wherein each of the first portions includes a ridge extending inwardly from that first portion towards the other first portion of the body.

10. The scleral prosthesis of claim 1, wherein one side of the first end and one side of the second end are aligned along a straight side of the body.

11. The scleral prosthesis of claim 1, further comprising:

an insert placed between or around the first portions of the body to maintain the separation of the first portions.

12. The system of claim 11, wherein:

each of the first portions includes a ridge extending inwardly from that first portion towards the other first portion of the body;

the ridges along the first portions of the body engage slots along the insert; and

the ridges and the slots are configured to limit movement of the insert so that, when the insert is inserted into the body, the insert only moves lengthwise along the body into the empty space between the first portions of the body.

13. The scleral prosthesis of claim 1, wherein the scleral prosthesis is adapted to increase an amplitude of accommodation in the eye.

14. A system comprising:

a scleral prosthesis configured to be implanted into scleral tissue of an eye, the scleral prosthesis comprising;

an elongated body having a first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body;

the body comprising multiple first portions that form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along at least half of a total length of the body from the first free end to the second free end by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

the body further comprising multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space;

wherein the first portions of the body are biased to maintain separation from one another without external interference but are configured to be pushed towards each other to reduce the width of the first end so that the second end is wider than a remainder of the body; and

a threader tube configured to receive at least part of the first portions of the body, the threader tube also configured to be transported through a scleral tunnel in the scleral tissue of the eye and to release the scleral prosthesis for implantation of the scleral prosthesis in the scleral tunnel.

15. The system of claim 14, wherein the threader tube is configured to push the first portions of the body towards each other to reduce the width of the body at the first end of the body.

16. The system of claim 14, further comprising:

a suture placed through the threader tube and looped over part of the scleral prosthesis.

17. The system of claim 16, wherein the suture comprises multiple loops configured to loop over multiple areas that project from the first and second sides of the body at the first end.

18. The system of claim 16, wherein the suture is looped over a central portion of the body, the suture located between the second portions of the body.

19. The system of claim 14, wherein:

the threader tube comprises a first end portion and a second end portion configured to receive the scleral prosthesis; and

the system further comprises a rod partially inserted into the first end portion of the threader tube.

20. The system of claim 19, wherein the rod comprises a tapered and rounded end configured to be inserted into the scleral tunnel ahead of the threader tube.

21. The system of claim 14, wherein:

the first portions run substantially parallel to one another along the length of the body; and

the second portions run substantially parallel to one another along the length of the body.

22. The system of claim 14, wherein the second portions are separated along less than a quarter of the length of the body.

23. The system of claim 14, wherein each of the first portions includes a ridge extending inwardly from that first portion towards the other first portion of the body.

24. The system of claim 14, wherein one side of the first end and one side of the second end are aligned along a straight side of the body.

25. A method comprising:

inserting at least part of a first free end of a scleral prosthesis into a threader tube, the scleral prosthesis comprising;

an elongated body having the first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each free end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body;

the body comprising multiple first portions that form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along at least half of a total length of the body from the first free end to the second free end by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

the body further comprising multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space;

wherein the first portions of the body are biased to maintain separation from one another without external interference but are configured to be pushed towards each other to reduce the width of the first end so that the second end is wider than a remainder of the body;

pulling the scleral prosthesis into a scleral tunnel in scleral tissue of an eye using the threader tube; and

removing the scleral prosthesis from the threader tube for implantation in the scleral tunnel.

26. The method of claim 25, further comprising:

looping a suture over a portion of the scleral prosthesis, wherein the suture is placed through the threader tube; and

pulling the scleral prosthesis into the scleral tunnel using the suture.

27. The method of claim 25, wherein:

the threader tube comprises a narrower first end and a wider second end;

at least a portion of the scleral prosthesis is inserted into the second end of the threader tube; and

the first end of the threader tube enters the scleral tunnel before the second end of the threader tube enters the scleral tunnel.

28. The method of claim 27, wherein:

a rod extends from the first end of the threader tube; and

the rod enters the scleral tunnel before the first end of the threader tube enters the scleral tunnel.

29. A scleral prosthesis comprising:

an elongated body having a first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body;

wherein the body comprises multiple first portions that form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along a substantial portion of the body by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

wherein the body further comprises multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space;

wherein the first portions of the body are biased to maintain separation from one another without external interference but are configured to be pushed towards each other to reduce the width of the first end so that the second end is wider than a remainder of the body; and

wherein the scleral prosthesis is configured to be implanted into scleral tissue of an eye.

30. A system comprising:

a scleral prosthesis configured to be implanted into scleral tissue of an eye, the scleral prosthesis comprising;

an elongated body having a first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body;

the body comprising multiple first portions that form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along at least about half of a total length of the body from the first free end to the second free end by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

the body further comprising multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space;

wherein the first portions of the body are biased to maintain separation from one another without external interference but are configured to be pushed towards each other to reduce the width of the first end so that the second end is wider than a remainder of the body; and

an insert configured to be placed between the first portions of the body to maintain the separation of the first portions.

31. The system of claim 30, wherein:

the first portions run substantially parallel to one another along the length of the body; and

the second portions run substantially parallel to one another along the length of the body.

32. The system of claim 30, wherein the second portions are separated along less than a quarter of the length of the body.

33. The system of claim 30, wherein each of the first portions includes a ridge extending inwardly from that first portion towards the other first portion of the body.

34. The system of claim 33, wherein:

the ridges along the first portions of the body engage slots along the insert; and

the ridges and the slots are configured to limit movement of the insert so that, when the insert is inserted into the body, the insert only moves lengthwise along the body into the empty space between the first portions of the body.

35. The system of claim 30, wherein one side of the first end and one side of the second end are aligned along a straight side of the body.

36. The system of claim 30, wherein the insert comprises a wider end portion that fits within a space proximate to a location where the first portions of the body meet.

37. A method comprising:

pushing first portions of an elongated body of a scleral prosthesis towards each other, the body of the scleral prosthesis having a first free end and a second free end opposite the first end along a length of the body, a maximum width of the body at each free end wider than a maximum width of the body between the ends, the width of the body between the ends measured from a first side of the body to an opposing second side of the body, wherein the first portions form the first end of the body and a part of the body between the ends, the first portions separated lengthwise along at least about half of a total length of the body from the first free end to the second free end by empty space, the first portions meeting at a point between the ends of the body and being unconnected from each other between that point and the first end of the body;

inserting at least part of the first portions of the body into a scleral tunnel in scleral tissue of an eye;

releasing the first portions of the body, the first portions of the body biased to maintain separation from one another without external interference but, when the first portions are pushed towards each other, the width of the first end is reduced and the second end is wider than a remainder of the body; and

placing an insert between the first portions of the body to maintain the separation of the first portions of the body;

wherein the body further comprises multiple second portions that form the second end of the body and another part of the body between the ends, the second portions separated lengthwise along the body by empty space.