Details for Patent: 7,604,185

Title:	Generation of therapeutic microfoam
Abstract:	Improved therapeutic sclerosing microfoams and methods and devices for making them are provided that have advantage in producing a consistent profile injectable foam with minimal input by the physician yet using high volume percentages of blood dispersible gases, thus avoiding use of potentially hazardous amounts of nitrogen.
Inventor(s):	Osman; Tariq (London, GB), Flynn; Sheila Bronwen (Nr. Stevenage, GB), Wright; David Dakin Iorwerth (High Wycombe, GB), Harman; Anthony David (Checkendon, GB), Boorman; Timothy David (Frinton on Sea, GB)
Assignee:	BTG International Ltd. (London, GB)
Filing Date:	Sep 14, 2005
Application Number:	11/225,860
Claims:	1. A microfoam comprising a gas component comprising a physiologically acceptable blood dispersible gas comprising 10 to 90% vol/vol carbon dioxide or a mixture of 10 to 90% vol/vol carbon dioxide with the remaining gas oxygen, and an aqueous sclerosant liquid suitable for use in sclerotherapy of blood vessels, wherein the microfoam has a density ranging from 0.07 g/ml to 0.19 g/ml. 2. A microfoam of claim 1 wherein said physiologically acceptable blood dispersible gas comprises 10 to 40% vol/vol carbon dioxide or a mixture of 10 to 40% carbon dioxide vol/vol and 60 to 90% vol/vol oxygen. 3. A microfoam of claim 1 wherein said physiologically acceptable blood dispersible gas comprises 20 to 30% vol/vol carbon dioxide or a mixture of 20 to 30% carbon dioxide vol/vol and 70 to 80% vol/vol oxygen. 4. A microfoam of claim 3 wherein said aqueous sclerosant liquid comprises 1% vol/vol polidocanol in an aqueous carrier. 5. A microfoam according to claim 1 wherein the density of the microfoam ranges from 0.09 g/ml to 0.16 g/ml. 6. A microfoam according to claim 1 wherein the density of the microfoam ranges from 0.11 g/ml to 0.14 g/ml. 7. A microfoam according to claim 1 wherein at least 50% by number of the gas bubbles of 25 .mu.m diameter and above are of no more than 200 .mu.m diameter and at least 95% of the gas bubbles of 25 .mu.m diameter and above are no more than 280 .mu.m diameter. 8. A microfoam according to claim 7 wherein at least 50% by number of the gas bubbles of 25 .mu.m diameter and above are of no more than 150 .mu.m diameter and at least 95% of the gas bubbles of 25 .mu.m diameter and above are no more than 250 .mu.m diameter. 9. A microfoam of claim 1 wherein said microfoam has a half-life of at least 2 minutes. 10. A microfoam of claim 1 wherein said microfoam has a half-life of at least 3 minutes. 11. A microfoam of claim 1 wherein said aqueous sclerosant liquid is a solution of polidocanol in an aqueous carrier or sodium tetradecylsulfate (STS) in an aqueous carrier. 12. A microfoam of claim 11 wherein the concentration of polidocanol ranges from 0.5 to 4% vol/vol in the liquid. 13. A method of angiologic treatment comprising injecting an effective amount of the microfoam of claim 1 into a vessel in need of angiologic treatment, and achieving sclerosis of the vessel. 14. A method of claim 13 wherein said microfoam comprises a gas component comprising a physiologically acceptable blood dispersible gas comprising 10 to 40% vol/vol carbon dioxide or a mixture of 10 to 40% carbon dioxide vol/vol and 60 to 90% vol/vol oxygen. 15. A method of claim 14 wherein said microfoam comprises an aqueous sclerosant liquid comprising 1% vol/vol polidocanol in an aqueous carrier. 16. A method of phlebologic treatment comprising injecting an effective amount of the microfoam of claim 1 into a vessel in need of phlebologic treatment, and achieving sclerosis of the vessel. 17. A method of claim 16 wherein said microfoam comprises a gas component comprising a physiologically acceptable blood dispersible gas comprising 10 to 40% vol/vol carbon dioxide or a mixture of 10 to 40% carbon dioxide vol/vol and 60 to 90% vol/vol oxygen. 18. A method of claim 17 wherein said microfoam comprises an aqueous sclerosant liquid comprising 1% vol/vol polidocanol in an aqueous carrier. 19. A method of treating varicose veins comprising injecting an effective amount of the microfoam of claim 1 into a vessel, and achieving sclerosis of the vessel. 20. A method of claim 19 wherein said microfoam comprises a gas component comprising a physiologically acceptable blood dispersible gas comprising 10 to 40% vol/vol carbon dioxide or a mixture of 10 to 40% carbon dioxide vol/vol and 60 to 90% vol/vol oxygen. 21. A method of claim 20 wherein said microfoam comprises an aqueous scierosant liquid comprising 1% vol/vol polidocanol in an aqueous carrier. 22. A method of treating an angioma comprising injecting an effective amount of the microfoam of claim 1 into a vessel and achieving sclerosis of the vessel. 23. A method of claim 22 wherein said microfoam comprises a gas component comprising a physiologically acceptable blood dispersible gas comprising 10 to 40% vol/vol carbon dioxide or a mixture of 10 to 40% carbon dioxide vol/vol and 60 to 90% vol/vol oxygen. 24. A method of claim 23 wherein said microfoam comprises an aqueous sclerosant liquid comprising 1% vol/vol polidocanol in an aqueous carrier. 25. A microfoam comprising a gas component comprising a physiologically acceptable blood dispersible gas comprising 20 to 30% vol/vol carbon dioxide or a mixture of 20 to 30% vol/vol carbon dioxide and 70 to 80% vol/vol oxygen, and an aqueous sclerosant liquid comprising polidocanol in an aqueous carrier or sodium tetradecylsulfate (STS) in an aqueous carrier, wherein the microfoam has a density ranging from 0.09 g/ml to 0.16 g/ml. 26. A microfoam of claim 25 wherein said aqueous scierosant liquid comprises 1% vol/vol polidocanol in an aqueous carrier. 27. A microfoam according to claim 25 wherein the density of the microfoam ranges from 0.11 g/ml to 0.14 g/ml. 28. A microfoam according to claim 25 wherein at least 50% by number of the gas bubbles of 25 .mu.m diameter and above are of no more than 200 .mu.m diameter and at least 95% of the gas bubbles of 25 .mu.m diameter and above are no more than 280 .mu.m diameter. 29. A microfoam according to claim 28 wherein at least 50% by number of the gas bubbles of 25 .mu.m diameter and above are of no more than 150 .mu.m diameter and at least 95% of the gas bubbles of 25 .mu.m diameter and above are no more than 250 .mu.m diameter. 30. A microfoam of claim 25 wherein said microfoam has a half-life of at least 2 minutes. 31. A microfoam of claim 25 wherein said microfoam has a half-life of at least 3 minutes. 32. A microfoam of claim 25 wherein said aqueous sclerosant liquid comprises 0.5 to 4% vol/vol polidocanol in an aqueous carrier. 33. A method of angiologic treatment comprising injecting an effective amount of the microfoam of claim 25 into a vessel in need of angiologic treatment, and achieving sclerosis of the vessel. 34. A method of treating varicose veins comprising injecting an effective amount of the microfoam of claim 25 into a vessel, and achieving sclerosis of the vessel. 35. A method of treating an angioma comprising injecting an effective amount of the microfoam of claim 25 into a vessel and achieving sclerosis of the vessel.