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Claims for Patent: 7,604,185

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Claims 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)
Application Number:11/225,860
Patent 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.
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