Injectable intraocular accommodating lens

• US 6,613,343 B2
• Filed: 04/12/2001
• Issued: 09/02/2003
• Est. Priority Date: 04/12/2000
• Status: Expired due to Term

• Current Assignee: Amo Groningen B.V (Johnson & Johnson)
• Original Assignee: Pharmacia Groningen BV (Johnson & Johnson)
• Inventors: Hilborn, Jöns Gunnar, Garamszegi, László, Haitjema, Hendrik Jan, Deuring, Hendrik, Dillingham, Keith Alfred, Hodd, Kenneth Albert
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US09/834,212
• Publication Number:
  US 20020071856A1
• Time in Patent Office: 873 Days
• Field of Search: 424/427, 424/70.12, 623/6.11
• US Class Current: 424/427
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C08L 83/08 containing silicon bound to organic groups containing atoms other than carbon, hydrogen and oxygen
• CPC Class Codes: G02B 1/043 Contact lenses

Abstract

The present invention relates to compositions comprising polysiloxanes suitable for the preparation of accommodating intraocular lenses, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula. The present invention includes intraocular lenses made from said polysiloxane compositions having a Young'"'"'s modulus less than about 10 kPa.

Claims

1. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens having a Young'"'"'s modulus less than about 10 kPa after injection into the capsular bag of the eye.

11. A composition according to claim 1 having a refractive index in the range of 1.38 to about 1.60.

12. A composition according to claim 1 wherein said polysiloxane composition comprises polysiloxanes having at least one siloxane monomer with a specific gravity greater than about 1.0.

13. A composition according to claim 12, wherein said polysiloxanes have a siloxane monomer —

R_aR_bSiO—

, wherein R_a and R_b are the same or different alkyl or phenyl groups of which at least one is substituted with one or several fluorine atoms.

18. A composition according to claim 1 having a specific gravity within the range of about 1.03 to 1.20 and a refractive index above about 1.38.

19. A composition according to claim 1 comprising functional polysiloxanes having crosslinkable groups attached, a crosslinking agent and optionally an effective amount of a catalyst.

34. A composition according to claim 1 having a viscosity less than about 60,000 cSt at room temperature.

40. A composition according to claim 1, adapted to form a lens having a Young'"'"'s modulus less than about 5 kPa.

2. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye and said polysiloxanes comprising fluoroalkyl(alkyl)siloxane monomer(s).

14. A composition according to claim 2, wherein said monomers comprise trifluoropropylmethylsiloxane monomer.

17. A composition according to claim 14, wherein said polysiloxanes comprise at least about 4 mol % trifluoropropylmethylsiloxane.

3. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye and said polysiloxanes being terpolymers or higher polymers of three or more siloxane monomer units, with at least one siloxane monomer having a specific gravity greater than about 1.0.

4. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye and said polysiloxanes comprising arylsiloxane monomer units, with at least one siloxane monomer having a specific gravity greater than about 1.0.

15. A composition according to claim 4, wherein said polysiloxanes comprise methyl and substituted methylsiloxanes, phenylsiloxanes and trifluoropropylsiloxanes.

16. A composition according to claim 15, wherein said polysiloxanes are terpolymers consisting essentially of (a) dimethylsiloxane, (b) methylphenylsiloxane or diphenylsiloxane and (c) trifluoropropylmethylsiloxane monomers.

5. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye and comprising functional polysiloxanes having vinyl groups capable of being crosslinked, at least one multifunctional silicone hydride crosslinking agent, and an effective amount of a platinum catalyst.

20. A composition according to claim 5, wherein the amount vinyl to hydride groups is larger than 1:

1.

21. A composition according to claim 5, wherein the amount vinyl to hydride groups is less than 1:

1.

22. A composition according to claim 5, wherein said crosslinking agent is a mixture of a difunctional hydride and a hydride with a higher functionality than two.

23. A composition according to claim 5, wherein said crosslinking agent is a tetrafunctional hydride.

24. A composition according to claim 5, wherein said crosslinking agent is a difunctional crosslinking agent.

25. A composition according to claim 24, wherein the non-functional polysiloxanes have sufficiently high molecular weight, so as to prevent diffusion through the capsular bag.

31. A composition according to claim 5, further comprising non-functional polysiloxanes, and wherein the amount of vinyl to hydride groups is about 1:

0.8, or higher.

32. A composition according to claim 31, wherein the amount of non-functional polysiloxanes is in excess to the functional polysiloxanes.

33. A composition according to claim 32, wherein the non-functional polysiloxanes are about 20% or less of the total amount of polysiloxanes.

6. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye and comprising a mixture of functional polysiloxanes having functional crosslinkable groups and non-functional polysiloxanes.

26. A composition according to claim 6, wherein the amount of non-functional polysiloxanes is within the range of about 30 to 93% (wt) of the total polysiloxane amount.

27. A composition according to claim 26, wherein the amount of non-functional polysiloxanes is within the range of about 50 to 93% (wt) of the total polysiloxane amount.

28. A composition according to claim 6, wherein the amount of non-functional polysiloxanes is within the range of about 20 to 50% (wt) of the total polysiloxane amount.

29. A composition according to claim 28 comprising vinyl substituted functional polysiloxanes and a multifunctional hydride crosslinking agent wherein the amount vinyl to hydride groups is larger than 1:

1.

30. A composition according to claim 28 comprising vinyl substituted functional polysiloxanes and a multifunctional hydride crosslinking agent wherein the amount vinyl to hydride groups is less than 1:

1.

7. An injectable ophthalmic composition of polysiloxanes having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye, being essentially free from non-functional polysiloxanes, and comprising polysiloxanes with functional vinyl groups and a multifunctional hydride crosslinking agent in a relative amount so as to provide an excess of vinyl groups to hydride groups.

8. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye, being essentially free from non-functional polysiloxanes, and comprising polysiloxanes with functional vinyl groups and a multifunctional hydride crosslinking agent in a relative amount so as to provide an excess of hydride groups to vinyl groups.

9. An accommodating intraocular lens having a value of Young'"'"'s modulus less than about 10 kPa that sufficiently remains stable over time, wherein said lens is made by injecting a polysiloxane composition into the capsular bag of the eye, the polysiloxane composition having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye.

35. A lens according to claim 9, having a Young'"'"'s modulus less than about 5 kPa.

36. A lens according to claim 9, having a refractive index in the range of 1.38 to about 1.60.

37. A lens according to claim 9, wherein the polysiloxane composition is crosslinked in the capsular bag of the eye at ambient eye temperature.

38. A lens according to claim 37, wherein a fraction of polysiloxanes in the polysiloxane composition does not participate in the crosslinking reaction.

39. A lens according to claim 38, wherein said fraction of non-crosslinked polysiloxanes have a sufficiently high molecular weight so as to substantially prevent diffusion of the polysiloxane composition through the capsular bag.

10. An injectable ophthalmic composition of polysiloxanes, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula, said composition being adapted to form an accommodating intraocular lens after injection into the capsular bag of the eye.