Low-oxygen fluorocarbon as an agent for ophthalmology

• US 6,372,243 B2
• Filed: 03/16/1999
• Issued: 04/16/2002
• Est. Priority Date: 03/18/1998
• Status: Expired due to Fees

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Pharm Pur GmbH
• Inventors: Dresp, Joachim, Kobuch, Karin, Menz, Dirk-Henning, Gabel, Veit-Peter
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US09/270,562
• Publication Number:
  US 20020001607A1
• Time in Patent Office: 1,127 Days
• Field of Search: 424/423
• US Class Current: 424/423
• CPC Class Codes: A61K 31/025 carbocyclic
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

The present invention concerns fluorocarbons for use in ophthalmology. Fluorocarbons disclosed in the prior art can only be left in the eye for a limited period of time because they cause damage to the retina or intraocular structure. The present invention provides an oxygen-fluorocarbon mixture having a dissolved oxygen content of less than 6% by volume, which can be used as an ophthalmological agent for longer periods of time than conventional fluorocarbons, with little or no damage to the retina or intraocular structures. The invention also provides a process for preparing the oxygen-fluorocarbon mixture. In one embodiment, up to 20% by volume of a second gas, such as carbon dioxide or nitric oxide, is combined with the oxygen-fluorocarbon mixtures.

Claims

1. An oxygen-physiologically acceptable fluorocarbon mixture having a dissolved oxygen content of less than 6-% by volume, wherein the fluorocarbon is selected from the class of saturated, perfluorinated hydrocarbons in which all of the hydrogen atoms are replaced by fluorinated atoms, or partially fluorinated alkanes having the general formula R_FR_H or R_FR_HR_F that can be present in a liquid or gel-like state, and wherein R_F is a perfluorinated alkyl group and R_H is an alkyl group.

2. An oxygen-fluorocarbon mixture according to claim 1, having a dissolved oxygen content of less than 4% by volume.

3. An oxygen-fluorocarbon mixture according to claim 1, having a dissolved oxygen content of less than 1% by volume.

4. An oxygen-fluorocarbon mixture according to claim 1, combined with a second gas, wherein said second gas constitutes between 0 and 20% by volume of the mixture.

5. An oxygen-fluorocarbon mixture according to claim 4 wherein said second gas is selected from the group consisting of carbon dioxide and nitric oxide.

6. A process for preparing an oxygen-physiologically acceptable fluorocarbon mixture having a dissolved oxygen content of less than 6% by volume, wherein the fluorocarbon is selected from the class of saturated, perfluorinated hydrocarbons in which all of the hydrogen atoms are replaced by fluorinated atoms, or partially fluorinated alkanes having the general formula R_FR_H or R_FR_HR_F that can be present in a liquid or gel-like state, wherein R_F is a perfluorinated alkyl group and R_H is an alkyl group;

and wherein the fluorocarbon is deoxygenated using a heterogeneous oxygen getter, and stored in an oxygen-lacking state until use.

7. A process according to claim 6 wherein said heterogeneous oxygen getter comprises a low-valence metal oxide.

8. A process according to claim 7, wherein said low-valence metal oxide is reduced Cu₂O.

9. A process according to claim 6, wherein said oxygen-lacking state is achieved by hermetic sealing.

10. A process according to claim 6, wherein said oxygen-fluorocarbon mixture is stored in a sealed container with said heterogeneous oxygen getter;

and filtered through a sterile filter prior to use.

11. A process according to claim 6, wherein said fluorocarbon is stored in a projecting gas chamber with said heterogeneous oxygen getter, until use.

12. A process according to claim 6, wherein said fluorocarbon is filtered through an absorber cartridge containing said heterogeneous oxygen getter and then filtered through a sterile filter.

13. A process for making an oxygen-physiologically acceptable fluorocarbon mixture having a dissolved oxygen content of less than 6% by volume, wherein the fluorocarbon is selected from the class of saturated, perfluorinated hydrocarbons in which all of the hydrogen atoms are replaced by fluorinated atoms, or partially fluorinated alkanes having the general formula R_FR_H or R_FR_HR_F that can be present in a liquid or gel-like state, and wherein R_F is a perfluorinated alkyl group and R_H is an alkyl group;

wherein said fluorocarbon is deoxygenated using a heterogeneous oxygen getter; and

proportionately mixed with an oxygen-containing fluorocarbon to obtain a desired oxygen concentration within a range of 0% to 6% by volume; and

stored in an oxygen-lacking state until use.

14. A method of using a physiologically acceptable fluorocarbon having a dissolved oxygen content of less than 6% by volume as an agent for ophthalmology, wherein the fluorocarbon is selected from the class of saturated, perfluorinated hydrocarbons in which all of the hydrogen atoms are replaced by fluorinated atoms, or partially fluorinated alkanes having the general formula R_FR_H or R_FR_HR_F that can be present in a liquid or gel-like state, and wherein R_F is a perfluorinated alkyl group and R_H is an alkyl group.

15. A method of use according to claim 14, wherein the dissolved oxygen content is less than 4% by volume.

16. A method of use according to claim 14, wherein the dissolved oxygen content is less than 1% by volume.

17. A method of use according claim 14, wherein the dissolved oxygen content is greater than 0% by volume.

18. A method of use according to claim 14, wherein said fluorocarbon is combined with a second gas to create a mixture, and wherein said second gas constitutes between 1 and 20% by volume of the mixture.

19. A method of using a fluorocarbon according to claim 14, as an intraocular agent.

20. A method of using a fluorocarbon according to claim 17, as an intraocular agent.

21. A method of using a fluorocarbon according to claim 14, as a retina tampon.

22. A method of using a fluorocarbon according to claim 17, as a retina tampon.

23. A method of using a fluorocarbon according to claim 14, as an agent for treating ischemic retinal disorders.

24. A method of using a fluorocarbon according to claim 17, as an agent for treating ischemic retinal disorders.

25. A method of using a fluorocarbon according to claim 14, as a vitreous body replacement.

26. A method of using a fluorocarbon according to claim 17, as a vitreous body replacement.