Btg International Limited

Ekos Corporation

Microsample Ltd.

Anthony David Harman

David Dakin Iorwerth Wright

Garry Hodges

Nikki Robinson

Geoffrey Dillwyn Moggridge

Adil Kadar

Tariq Osman

Hugh Van Liew

Timothy David Boorman

Sheila Bronwen Shilton-Brown

Sheila Bronwen Flynn

David Dakin Wright

Stuart Brian William Kay

Andrew Gordon Pocock

Mark Yeoman

Neil Pollock

Jan Willem Marinus Mijers

Christopher John Hurlstone

Brendan Hogan

Gary Stewart Sinclair

David Dakin Iowerth Wright

David John Targell

Paul Harper

Jeremy Francis Donnan

William John Jenkins

Julian Richard Dixon

John Maclaren Cassells

Jam Wilem Marinus Mijers

Julina Richard Dixon

Jam Willem Marinus Mijers

David Wright

Jan Willem Mijers

Stuart Brian Kay

Paul V Harper

Mark Simpson Yeoman

Garry c/o Btg International Ltd Hodges

Geoffrey D Departof Chem Engineering Moggridge

Adil c/o Btg International Ltd Kadar

Geoffrey D University Of Cambridge Moggridge

Gary Hodges

Sheila Shilton-Brown

David DI Wright

Sheila Bronwen Shilton-brown

A device is described for facilitating the preparation of therapeutic foam e.g. for the treatment of varicose veins. A pressurised vial contains a sclerosant liquid, e.g., polidocanol solution, and a sterile gas which is readily absorbed by the body, e.g., carbon dioxide, oxygen or a mixture of these gases. The vial is provided either with a specialised stopper/seal into which a syringe nozzle may be inserted or alternatively a septum seal which may be penetrated by a hypodermic needle. The quantities of gas and liquid and the pressure in the vial are pre-set so that, on connection of a syringe to the vial, a predetermined volume of both gas and liquid is transferred to the syringe, with the intention that the syringe is then used to make a foam by known means. The use of the vial ensures that the ratio of gas to liquid in the foam is standardised, and also provides a convenient way of packaging the gas and liquid and of filling the syringe in a sterile manner.

Preparation of therapeutic foam

Vessel having sterile contents containing in predetermined proportions (i) a foamable liquid and (ii) a gas or gas mixture other than air. The contents are at a pressure above atmospheric pressure. The vessel has an outlet which is adapted to cooperate with a syringe nozzle and which has associated with it a breakable seal or a valve.

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 pressurized 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 minimizing 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.

Therapeutic foam

Method for producing a microfoam suitable for use in scleropathy of blood vessels by introducing a physiologically acceptable blood-dispersible gas into a container holding an aqueous sclerosant liquid and releasing the mixture of blood-dispersible gas and sclerosant liquid such that, upon release of the mixture, the components of the mixture interact to form a microfoam. The container is provided with a steam-sterilizable aerosol valve having a valve body of polymeric material having an HDT (heat deflection temperature) at 1.8 MPa stress in the range of 200-275 &#xb0; C.

Aerosol valve

A steam-sterilizable aerosol valve has a valve body of polymeric material such as polyphenylene sulfone (PPSU) having an HDT (heat deflection temperature) at 1.8 MPa stress in the range of 200-275&#xb0; C. Such a valve has the ability to survive steam sterilization without significant degradation of properties or appearance.

Device containing sclerosant liquid for use in the treatment of blood vessels having an aerosol valve housing containing gas-entry ports. The aerosol valve housing is mounted on a canister having an expandable inner container in which the sclerosant fluid is contained. The expandable inner container is affixed to the outer opening of the canister or to the aerosol valve housing above the valve gas-entry ports so that gas taken from the interior of the expandable inner container can mix with the sclerosant liquid to create a micro foam, such that introduction of pressurized gas through the aerosol valve causes the expandable inner container to inflate to accommodate the pressurized gas.

Container for the generation of therapeutic microfoam

A device and a method for generating therapeutic foam from a sclerosing solution such as polidocanol and a gas which is absorbable or dissolvable in the body comprises a disposable cassette including a liquid container and a flexible chamber containing gas, chamber being formed as a loop. Located in the loop chamber is a foam generating mesh. In use, liquid is introduced into the chamber and then the cassette is inserted into a pumping machine where it is engaged by a peristaltic pump which circulates the contents of the loop chamber through the mesh, thus creating foam. When a steady state is reached, foam may be withdrawn using a syringe via either a port or septum.

Device and method for producing therapeutic foam

A foam transfer device is described, for use with aerosol canister apparatus for producing a sclerosant foam for the treatment of, inter alia, varicose veins. The device enables diversion of an initial quantity of below-specification foam from the canister to waste, e.g. to an integral waste chamber, before dispensing a further quantity of foam for use in treatment. The switching of the flow from the waste chamber to a different outlet for use is accomplished without interrupting the flow from the aerosol canister since this would cause the foam to drop below specification again. The waste chamber may be transparent so that the foam entering it can be observed and a decision made by a user when to stop diverting foam to waste. Alternatively, the foam may be diverted automatically e.g. when a set time has elapsed or a set volume of foam dispensed. The foam for use is normally dispensed into a syringe for subsequent injection into a varicose vein of a patient.

Apparatus and method for dispensing foam

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.

Generation of therapeutic microfoam

A medical device having a housing () with a bore () and a lancet () slidably fitting in the bore. The lancet operates as a positive displacement piston. In a retracted position, in which the lancet is rearwardly displaced along the bore to define a fluid-containing space in the bore forwardly on the lancet tip, the fluid-containing space has a cross-section dimension to allow fluid to be retained therein by surface tension. The device has a seal () operable substantially to prevent flow of fluid from the fluid-containing space past the seal means on movement of the lancet. Displacement of the lancet between the puncture and retracted positions provides suction for drawing fluid into and along the fluid-containing space from the forward end of the bore, and/or pressure for expelling fluid from the fluid-containing space via the forward end of the bore. Also disclosed are methods for operating the device.

Method and apparatus for sampling and analysis of fluids

A method for producing a microfoam suitable for use in scleropathy of blood vessels comprises introducing a physiologically acceptable blood-dispersible gas into a container () holding an aqueous sclerosant liquid and releasing the mixture of blood-dispersible gas and sclerosant liquid, whereby upon release of the mixture the components of the mixture interact to form a microfoam.

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Henley-on-Thames, United Kingdom

Anthony David Harman