Generation of therapeutic microfoam

• US 7,604,185 B2
• Filed: 09/14/2005
• Issued: 10/20/2009
• Est. Priority Date: 05/26/1999
• Status: Expired due to Fees

• Current Assignee: BTG International Limited (Boston Scientific Corporation)
• Original Assignee: BTG International Limited (Boston Scientific Corporation)
• Inventors: Harman, Anthony David, Wright, David Dakin Iorwerth, Flynn, Sheila Bronwen, Boorman, Timothy David, Osman, Tariq
• Primary Examiner(s): Doerrler; William C
• Application Number:
  US11/225,860
• Publication Number:
  US 20060049269A1
• Time in Patent Office: 1,497 Days
• Field of Search: 239/337, 424/400, 424/423, 424/600, 514/945
• US Class Current: 239/337
• CPC Class Codes: A61K 31/08 acyclic, e.g. paraformaldehyde
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons
• CPC Class Codes: B05B 7/0037 including sieves, porous members or the like
• CPC Class Codes: B65D 83/14 for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
• CPC Class Codes: B65D 83/20 operated by manual action, e.g. button-type actuator or actuator caps actuators formed as a rigid elongate spout B65D83/306
• CPC Class Codes: B65D 83/48 Lift valves, e.g. operated by push action B65D83/50 takes precedence
• CPC Class Codes: B65D 83/60 Contents and propellant separated
• CPC Class Codes: B65D 83/62 by membrane, bag, or the like containers in which the content is delivered by the contracting forces inherent in the bag B65D83/0061

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.

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 μ

m diameter and above are of no more than 200 μ

m diameter and at least 95% of the gas bubbles of 25 μ

m diameter and above are no more than 280 μ

m diameter.

8. A microfoam according to claim 7 wherein at least 50% by number of the gas bubbles of 25 μ

m diameter and above are of no more than 150 μ

m diameter and at least 95% of the gas bubbles of 25 μ

m diameter and above are no more than 250 μ

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 μ

m diameter and above are of no more than 200 μ

m diameter and at least 95% of the gas bubbles of 25 μ

m diameter and above are no more than 280 μ

m diameter.

29. A microfoam according to claim 28 wherein at least 50% by number of the gas bubbles of 25 μ

m diameter and above are of no more than 150 μ

m diameter and at least 95% of the gas bubbles of 25 μ

m diameter and above are no more than 250 μ

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.