Therapeutic foam

• US 20060062736A1
• Filed: 11/17/2004
• Published: 03/23/2006
• Est. Priority Date: 11/17/2003
• Status: Abandoned Application

• Current Assignee: BTG International Limited (Boston Scientific Corporation)
• Original Assignee: BTG International Limited (Boston Scientific Corporation)
• Inventors: Harman, Anthony David, Kadar, Adil, Wright, David Dakin Iorwerth, Robinson, Nikki, Hodges, Garry
• Application Number:
  US10/522,525
• Publication Number:
  US 20060062736A1
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61K 31/08 acyclic, e.g. paraformaldehyde
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• 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 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61K 9/124 characterised by the propellant
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 2202/00 Special media to be introduced, removed or treated
• CPC Class Codes: A61M 2210/086 Legs
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61P 41/00 : Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• 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: B01F 23/235 : for making foam
• CPC Class Codes: B01F 25/4512 : with reciprocating pistons
• CPC Class Codes: B01F 25/4523 : the components being pressed through sieves, screens or meshes which obstruct the whole diameter of the tube
• CPC Class Codes: B01F 33/50112 : of the syringe or cartridge type
• CPC Class Codes: B65B 3/003 : Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 31/00 : Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers

Abstract

A therapeutic foam for the treatment of, inter alia, varicose veins comprises a sclerosing solution foamed with a physiological gas such as carbon dioxide, oxygen or a mixture thereof. The foam has a nitrogen content of less than 0.8%. It may be generated using a pressurised canister system incorporating a fine mesh of micron dimensions through which the gas and sclerosing liquid are passed to make the foam. Alternatively, the foam may be generated by passing gas and solution between two syringes through a fine mesh. Techniques are described for minimising the amount of nitrogen in a canister or syringe based product. A technique for generating and delivering foam simultaneously using a syringe based device is also disclosed.

Claims

1. A foam comprising a liquid phase and a gas phase wherein

the liquid phase comprises at least one sclerosing agent and is at least 20% vol/vol of at least one viscosity enhancing agent;

and

the gas phase comprises at least 50% CO2;

and wherein the foam has a density less than 0.25 g/ml and half life of greater than 100 secs.

4. A foam of claim 1, wherein the gas phase comprises at least 99% CO2.

5. A foam of claim 1, wherein the gas phase consists essentially of CO2.

8. A foam of claim 1, wherein the half life is at least 180 seconds.

9. A foam of claim 1, wherein the density ranges from 0.07 to 0.22 g/ml.

12. A foam of claim 1, wherein the density ranges from 0.08 to 0.14 g/ml.

13. A foam of claim 1, wherein the gas phase further comprises another physiologically acceptable gas that is dispersible in blood.

14. A foam of claim 1, wherein the gas phase further comprises O2.

15. A foam of claim 1, wherein the gas phase consists essentially of CO2 and O2.

16. A foam of claim 1, wherein the at least one viscosity enhancing agent is chosen from glycerol and PVP.

18. A foam of claim 1, wherein the at least one sclerosing agent is chosen from polidocanol, glycerol and sodium tetradecyl sulphate.

19. A foam of claim 1, wherein the at least one sclerosing agent is polidocanol.

20. A foam of claim 1, wherein the polidocanol is present in a concentration ranging from 0.5 to 4% vol/vol in the liquid phase.

21. A foam of claim 1, wherein the liquid phase further comprises water and/or saline solution.

22. A foam of claim 1, wherein the liquid phase further comprises alcohol.

23. A foam of claim 1, wherein the saline solution is phosphate buffered saline with a pH ranging from 6.0 to 8.0.

24. A foam of claim 1, wherein the foam is capable of being passed down a 21 gauge needle such that 50% or more by number of its gas bubbles of at least 25 μ

m remain at 150 μ

m diameter or less and at least 95% of these bubbles at 280 μ

m diameter or less.

25. A foam of claim 1, wherein at least 50% by number of the gas bubbles of at least 25 μ

m diameter are of no more than 120 μ

m diameter and at least 95% of these gas bubbles are of no more than 250 μ

m.

26. A method for angiologic treatment comprising injecting a foam of claim 1 into vessels to be treated.

27. A method for phlebologic treatment comprising injecting a foam of claim 1 into vessels to be treated.

28. The method of claim 25 wherein substantially the entire greater saphenous vein of one leg of a human patient is treated by a single injection of foam.

29. The method of claim 27 wherein the single injection uses an amount ranging from 10 ml to 50 ml of foam.

31. The method of claim 27 wherein the single injection uses an amount ranging from 15 ml and 30 ml.

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64. A method for producing a foam comprising

passing a mixture comprising at least one physiologically acceptable blood dispersible gas and at least one aqueous sclerosant liquid through one or more passages having at least one cross-sectional dimension of from 0.1 to 15 μ

m,

the ratio of gas to liquid being controlled such that the foam is produced having a density less than 0.25 g/cm and a half-life of greater than 100 secs.

65. The method of claim 64, wherein the physiologically acceptable blood dispersible gas is chosen from CO2, O2 and mixtures thereof.

66. The method of claim 64, wherein the physiologically acceptable blood dispersible gas is at least 50% C02.

69. The method of claim 64, wherein the physiologically acceptable blood dispersible gas comprises at least 99% CO2.

70. The method of claim 64, wherein the physiologically acceptable blood dispersible gas consists essentially of CO2.

71. The method of claim 64, wherein the half life is at least 120 seconds

73. The method of claim 64, wherein the half life is at least 180 seconds.

74. The method of claim 64, wherein the density ranges from 0.07 to 0.19 g/ml.

75. The method of claim 64, wherein the mixture further comprises at least 20% vol/vol of at least one viscosity enhancing agent.

76. The method of claim 75, wherein the at least one viscosity enhancing agent is chosen from glycerol and PVP.

78. The method of claim 64, wherein the at least one sclerosing agent is chosen from polidocanol, glycerol and sodium tetradecyl sulphate.

79. The method of claim 78, wherein the at least one sclerosing agent is polidocanol.

80. The method of claim 64, wherein the foam has a viscosity ranging from ranging from 2.0 to 3.5 cP.

81. The method of claim 64, wherein the foam is capable of being passed down a 21 gauge needle such that 50% or more by number of its gas bubbles of at least 25 μ

m remain at 150 μ

m diameter or less and at least 95% of these bubbles at 280 μ

m diameter or less.

82. The method of claim 64, wherein at least 50% by number of the gas bubbles of at least 25 μ

m diameter are of no more than 120 μ

m diameter and at least 95% of these gas bubbles are of no more than 250 μ

m.

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