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

• US 9,452,044 B2
• Filed: 12/18/2015
• Issued: 09/27/2016
• Est. Priority Date: 07/11/2006
• Status: Active Grant

• Current Assignee: Refocus Group Incorporated
• Original Assignee: Refocus Group Incorporated
• Inventors: Jacobson, Harry R. A., Griffis, Jack C. III, Cox, Mark A., Williamson, Douglas C., Zdenek, Gene W., Richardson, Peter J., Smolek, Michael K., Soloway, Barrie D., Bare, Rex O., Scherer, Andrew J., Payne, Timothy J.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): Blanco, Javier
• Application Number:
  US14/975,205
• Publication Number:
  US 20160166378A1
• Time in Patent Office: 284 Days
• Field of Search: 623/4.1, 604/8
• US Class Current: 1/1
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• 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 2/1624 having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• 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
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

A scleral prosthesis includes an elongated body configured to be implanted into scleral tissue of an eye. The elongated body includes (i) opposing first and second ends and (ii) multiple first portions that form the first end of the body and part of a remainder of the body between the ends. The first and second ends are wider than the remainder of the body. The first portions of the body are separated lengthwise along the body by empty space such that the first portions meet at a point between the first and second ends of the body and are not connected to each other between that point and the first end. The scleral prosthesis also includes an insert configured to be placed and retained between the first portions of the body. The insert has a length that is at least about half of a length of the elongated body.

Claims

1. A scleral prosthesis comprising:

an elongated body configured to be implanted into scleral tissue of an eye, the elongated body comprising (i) opposing first and second free ends and (ii) multiple first portions that form the first end of the body and part of a remainder of the body between the first and second ends, the first and second ends wider than the remainder of the body, the first portions of the body separated lengthwise along at least about half of a total length of the body by empty space such that the first portions meet at a point between the first and second ends of the body and are not connected to each other between that point and the first end of the body; and

an insert configured to be placed and retained between the first portions of the body, wherein the insert has a length that is at least about half of the total length of the elongated body;

wherein at least a portion of the insert comprises a shape complementary to a shape of the empty space; and

wherein the insert is configured to be inserted lengthwise into the empty space.

2. The scleral prosthesis of claim 1, wherein:

the insert is configured, when inserted between the first portions of the body, to extend from the first end of the body beyond a midpoint of the body between the first and second ends.

3. The scleral prosthesis of claim 1, wherein:

the first portions of the body are biased so that they maintain separation from one another without external interference but are configured to be pushed towards each other; and

the insert is configured, after insertion between the first portions of the body, to maintain the separation of the first portions of the body.

4. The scleral prosthesis of claim 1, wherein the body further comprises multiple second portions that form the second end of the body and another part of the remainder of the body.

5. The scleral prosthesis of claim 4, wherein:

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

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

6. The scleral prosthesis of claim 4, wherein the second portions of the body are separated along less than a quarter of the total length of the body.

7. The scleral prosthesis of claim 1, wherein:

the first portions of the body include a right first portion and a left first portion;

the right first portion includes a first ridge extending inwardly from the right first portion towards the left first portion;

the left first portion includes a second ridge extending inwardly from the left first portion towards the right first portion; and

the ridges are configured to engage with slots of the insert.

8. The scleral prosthesis of claim 1, wherein the empty space tapers from a first larger width adjacent the first end to a smaller width and then expands to a second larger width adjacent the point where the first portions of the body meet.

9. The scleral prosthesis of claim 1, wherein the insert tapers from a first larger width at one end of the insert to a smaller width and then expands to a second larger width at another end of the insert.

10. The scleral prosthesis of claim 1, wherein at least one of the body and the insert comprises at least one magnetic material.

11. A method comprising:

obtaining an elongated body of a scleral prosthesis configured to be implanted into scleral tissue of an eye, the elongated body comprising (i) opposing first and second free ends and (ii) multiple first portions that form the first end of the body and part of a remainder of the body between the first and second ends, the first and second ends wider than the remainder of the body, the first portions of the body separated lengthwise along at least about half of a total length of the body by empty space such that the first portions meet at a point between the first and second ends of the body and are not connected to each other between that point and the first end of the body; and

placing an insert between the first portions of the body, wherein the insert has a length that is at least about half of the total length of the elongated body;

wherein at least a portion of the insert comprises a shape complementary to a shape of the empty space; and

wherein the insert is configured to be inserted lengthwise into the empty space.

12. The method of claim 11, wherein the insert, when inserted between the first portions of the body, extends from the first end of the body beyond a midpoint of the body between the first and second ends.

13. The method of claim 11, wherein:

the first portions of the body are biased so that they maintain separation from one another without external interference but are configured to be pushed towards each other; and

the insert is configured, after insertion between the first portions of the body, to maintain the separation of the first portions of the body.

14. The method of claim 11, wherein the body further comprises multiple second portions that form the second end of the body and another part of the remainder of the body.

15. The method of claim 14, wherein:

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

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

16. The method of claim 14, wherein the second portions of the body are separated along less than a quarter of the total length of the body.

17. The method of claim 11, wherein:

the first portions of the body include a right first portion and a left first portion;

the right first portion includes a first ridge extending inwardly from the right first portion towards the left first portion;

the left first portion includes a second ridge extending inwardly from the left first portion towards the right first portion; and

the ridges are configured to engage with slots of the insert.

18. The method of claim 11, wherein the insert tapers from a first larger width at one end of the insert to a smaller width and then expands to a second larger width at another end of the insert.

19. The method of claim 11, wherein at least one of the body and the insert comprises at least one magnetic material.

20. A method comprising:

forming an elongated body of a scleral prosthesis configured to be implanted into scleral tissue of an eye, the elongated body comprising (i) opposing first and second free ends and (ii) multiple first portions that form the first end of the body and part of a remainder of the body between the first and second ends, the first and second ends wider than the remainder of the body, the first portions of the body separated lengthwise along at least about half of a total length of the body by empty space such that the first portions meet at a point between the first and second ends of the body and are not connected to each other between that point and the first end of the body; and

forming an insert configured to be placed and retained between the first portions of the body, wherein the insert has a length that is at least about half of the total length of the elongated body;

wherein at least a portion of the insert comprises a shape complementary to a shape of the empty space; and

wherein the insert is configured to be inserted lengthwise into the empty space.