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|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), Shilton-Brown; Sheila Bronwen (Brentwood, GB), Wright; David Dakin Iorwerth (High Wycombe, GB), Harman; Anthony David (Henley-on-Thames, GB), Boorman; Timothy David (Frinton on Sea, GB)|
|Assignee:||BTG International Limited (London, GB)|
|Filing Date:||Jun 18, 2009|
|Claims:||1. A method for producing a microfoam suitable for use in sclerotherapy of blood vessels characterized in that it comprises passing a mixture of a physiologically acceptable blood dispersible gas, wherein said gas comprises at least 50% vol/vol carbon dioxide, and an aqueous sclerosant liquid through one or more passages, the ratio of gas to liquid being controlled such that a microfoam is produced having a density of between 0.07 g/ml to 0.19 g/ml and has a half-life of at least 2 minutes. |
2. A method as claimed in claim 1 the gas/liquid ratio in the mixture is controlled such that the density of the microfoam is 0.09 g/mL to 0.16 g/mL.
3. A method as claimed in claim 1 characterized in that 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 these gas bubbles are no more than 280 .mu.m diameter.
4. A method as claimed in claim 1 characterized in that 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 these gas bubbles are no more than 250 .mu.m diameter.
5. A method as claimed in claim 1 characterized in that the mixture of gas and sclerosant liquid is in the form of an aerosol, dispersion of bubbles in liquid or macrofoam.
6. A method as claimed in claim 1 characterized in that the ratio of gas to liquid used in the mixture is 1 gram sclerosant liquid to from 6.25 to 14.3 volumes of gas at standard temperature and pressure.
7. A method as claimed in claim 1 characterized in that the physiologically acceptable blood dispersible gas comprises a major proportion of carbon dioxide and/or oxygen.
8. A method as claimed in claim 1 characterized in that the aqueous sclerosant liquid is a solution of polidocanol or sodium tetradecylsulfate (STS) in an aqueous carrier.
9. A method as claimed in claim 8 characterized in that the carrier comprises a saline solution.
10. A method as claimed in claim 1 characterized in that the mixture of gas and liquid is passed through the same passage or passages a number of times.
11. A method as claimed in claim 1 characterized in that the gas is pressurized at 0.1 to 9 bar over atmospheric pressure.
12. A method as claimed in claim 11 characterized in that the gas is pressurized at 0.1 to 3 bar over atmospheric pressure.
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