Prosthetic capsular devices, systems, and methods

• US 9,358,103 B1
• Filed: 12/14/2015
• Issued: 06/07/2016
• Est. Priority Date: 02/10/2015
• Status: Active Grant

• Current Assignee: Omega Ophthalmics LLC
• Original Assignee: Omega Ophthalmics LLC
• Inventors: Wortz, Gary N., Ifland, Rick William
• Primary Examiner(s): Blanco, Javier
• Application Number:
  US14/968,427
• Time in Patent Office: 176 Days
• Field of Search: 623/6.38, 623/6.39, 623/6.4, 623/6.41, 623/6.43
• US Class Current: 1/1
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/16 Intraocular lenses
• CPC Class Codes: A61F 2/1648 Multipart lenses
• CPC Class Codes: A61F 2/1691 Packages or dispensers for intraocular lenses for contact lenses A45C11/005
• CPC Class Codes: A61F 2/1694 Capsular bag spreaders therefor
• CPC Class Codes: A61F 2002/1681 having supporting structure for lens, e.g. haptics
• CPC Class Codes: A61F 2002/1689 having plate-haptics
• CPC Class Codes: A61F 2002/169 Surrounding optic
• CPC Class Codes: A61F 2002/16901 Supporting structure conforms to shape of capsular bag
• CPC Class Codes: A61F 2002/16902 Separable from intraocular lens
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

A prosthetic capsular device configured to be inserted in an eye includes a housing structure and a ring structure. The housing structure includes a first side, a second side opposite the first side, a third side, a fourth side opposite the third side, a posterior side including a refractive surface, an anterior side opposite the posterior side, and a longitudinal axis. The first side, the second side, the third side, the fourth side, the posterior side, and the anterior side at least partially define a cavity configured to contain an intraocular device (e.g., an IOL). The anterior side includes an opening. The ring structure includes a ring structure portion extending radially outward from proximate one of an end of the first side and an end of the second side.

Claims

1. A prosthetic capsular device for insertion into a natural capsular bag of an eye after removal of a cataract, the device comprising:

a housing structure capable of containing an intraocular lens (IOL), the housing structure comprising a first material, the housing structure including;

a first flat lateral side, the first flat side including;

a first end, and

a second end;

a second flat lateral side opposite the first flat side, the second flat side including;

a first end, and

a second end;

a third arcuate lateral side extending between the first end of the first flat side and the first end of the second flat side;

a fourth arcuate lateral side extending between the second end of the first flat side and the second end of the second flat side, the fourth arcuate side opposite the third arcuate side;

a posterior side including;

a refractive surface, and

a posterior fin;

an anterior side opposite the posterior side, the anterior side including;

an opening configured to allow insertion of an intraocular lens, and

a round lip around the opening; and

a longitudinal axis,

wherein the housing structure is fully enclosed all around except at said opening, the first flat lateral side, the second flat lateral side, the third arcuate lateral side, the fourth arcuate lateral side, the posterior side, and the anterior side at least partially defining a cavity, the cavity of the housing structure capable of containing an intraocular lens; and

a ring structure comprising a second material different than the first material, the ring structure transverse to the longitudinal axis and at a position along the longitudinal axis, the ring structure including;

a first ring structure portion extending from proximate to the first end of the first flat side radially outward and towards the second end of the first flat side, the first ring structure portion anchored in the first flat side and the third arcuate side, the first ring structure portion comprising a capsular bag-contacting surface;

a second ring structure portion extending from proximate to the second end of the first flat side radially outward and towards the first end of the first flat side, the second ring structure portion anchored in the first flat side and the fourth arcuate side, the second ring structure portion comprising a capsular bag-contacting surface;

a third ring structure portion extending from proximate to the first end of the second flat side radially outward and towards the second end of the second flat side, the third ring structure portion anchored in the second flat side and the third arcuate side, the third ring structure portion comprising a capsular bag-contacting surface; and

a fourth ring structure portion extending from proximate to the second end of the second flat side radially outward and towards the first end of the second flat side, the fourth ring structure portion anchored in the second flat side and the fourth arcuate side, the fourth ring structure portion comprising a capsular bag-contacting surface,

each of the first ring structure portion, the second ring structure portion, the third ring structure portion, and the fourth ring structure portion including an anterior-posterior opening proximate to a terminal end;

the housing structure further comprising a bulge extending radially outward from anchor points of the ring structure,

each of the first flat side, the second flat side, the third arcuate side, and the fourth arcuate side including;

a first portion extending parallel to the longitudinal axis from the posterior side towards the anterior side to at least the position of the ring structure along the longitudinal axis and

a second portion extending radially inwardly from the first portion towards the lip of the anterior side.

2. The device of claim 1, wherein the first material comprises silicone and the second material comprises polyimide.

3. The device of claim 1, wherein the refractive surface has a refractive power between −

35 D and +35D.

4. The device of claim 1, wherein the opening is oblong.

5. The device of claim 4, wherein a ratio of a length of the opening along a major axis of the device to a length of the opening along a minor axis of the device is between about 1:

2 and about 2;

1.

6. The device of claim 4, wherein the opening has a length between about 6 mm and about 8 mm along a major axis of the device and length between about 5 mm and about 7 mm along a minor axis of the device.

7. The device of claim 1, wherein the first material comprises silicone.

8. The device of claim 1, wherein the second material comprises polyimide.

9. The device of claim 1, wherein the posterior side includes a plurality of posterior fins including the posterior fin.

10. The device of claim 9, wherein the plurality of posterior fins comprises the posterior fin and a second posterior fin, the posterior fin and the second posterior fin circumferentially offset by about 180°

.

11. The device of claim 10, wherein the posterior fin and the second posterior fin are aligned along a major axis of the device.

12. The device of claim 11, wherein the refractive surface comprises a toric lens.

13. The device of claim 1, wherein the posterior fin protrudes posterior to the posterior side.

14. The device of claim 1, wherein the first, second, third, and fourth ring structure portions have a single radius of curvature.

15. The device of claim 1, wherein the first, second, third, and fourth ring structure portions extend from the housing structure at a position anterior to a longitudinal midline of the device.

16. The device of claim 1, wherein the housing structure is stretchable up to about 200% without damage.

17. The device of claim 1, wherein the refractive surface is stretchable by between about 110% and about 600% along a minor axis of the device.

18. The device of claim 1, wherein the refractive surface has a diameter between about 4 mm and about 9 mm.

19. The device of claim 1, wherein the refractive surface has a negative diopter value less than −

35 D.

20. The device of claim 1, wherein the refractive surface has a positive diopter value greater than ±

35 D.

21. The device of claim 1, wherein the device is configured to self-expand from a folded state to an unfolded state.

22. The device of claim 1, wherein the housing structure is overmolded around the first, second, third, and fourth ring structure portions.

23. The device of claim 1, wherein the first, second, third, and fourth ring structure portions are individually anchored to the housing structure.

24. The device of claim 1, wherein the first, second, third, and fourth ring structure portions are anchored to the housing structure by anchors extending partially along one of the first flat lateral side and the second flat lateral side.

25. The device of claim 1, wherein the anterior-posterior openings of the first, second, third, and fourth ring structure portions have a diameter between about 0.2 mm and about 0.3 mm.