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Generation-of-therapeutic-microfoam

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Generation of therapeutic microfoam

Details

Inventors: Osman, Tariq; Flynn, Sheila Bronwen; Wright, David Dakin Iorwerth; Harman, Anthony David; Boorman, Timothy David;
Assignee: BTG International Limited (London, GB)
Primary Examiner: Travers; Russell
Assistant Examiner: Sharareh; S
Attorney, Agent or Firm: Nixon & Vanderhye

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.

DETAILED DESCRIPTION What is claimed is: 1.
A method for producing a microfoam suitable for use in sclerotherapy of blood vessels said microfoam comprising gas bubbles in which 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, said method comprising passing a mixture of a physiologically acceptable blood dispersible gas capable of being substantially completely dissolved in or absorbed by blood and an aqueous sclerosant liquid through one or more passages having at least one cross-sectional dimension of from 0.
1 to 30 .
mu.
m, 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, to produce said microfoam, said microfoam being formed without the prior step of beating with a brush.
2.
A method as described in claim 1 wherein 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 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 these gas bubbles are no more than 250 .
mu.
m diameter.
4.
A method as claimed in claim 1 wherein the mixture of gas and sclerosant liquid is in the form of an aerosol, dispersion of bubbles in liquid or macrofoam.
5.
A method as claimed in claim 1 wherein the ratio of gas to liquid used in the mixture is 1 gram sclerosant liquid to form 6.
25 to 14.
3 volumes of gas as standard temperature and pressure.
6.
A method as claimed in claim 1 wherein the physiologically acceptable blood dispersible gas comprises over 50% volume of carbon dioxide and/or oxygen.
7.
A method as claimed in claim 1 wherein the aqueous sclerosant liquid is a solution of polidocanol or sodium tetradecylsulfate (STS) in an aqueous carrier.
8.
A method as claimed in claim 7 wherein the carrier comprises a saline solution

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