CA2429674A1 - Generation of therapeutic microfoam - Google Patents

Generation of therapeutic microfoam Download PDF

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Publication number
CA2429674A1
CA2429674A1 CA002429674A CA2429674A CA2429674A1 CA 2429674 A1 CA2429674 A1 CA 2429674A1 CA 002429674 A CA002429674 A CA 002429674A CA 2429674 A CA2429674 A CA 2429674A CA 2429674 A1 CA2429674 A1 CA 2429674A1
Authority
CA
Canada
Prior art keywords
blood
mixture
gas
dispersible
dispersible gas
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002429674A
Other languages
French (fr)
Other versions
CA2429674C (en
Inventor
Anthony David Harman
Paul V. Harper
Neil Pollock
Gary Stewart Sinclair
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BTG International Ltd
Original Assignee
Btg International Limited
Anthony David Harman
Paul V. Harper
Neil Pollock
Gary Stewart Sinclair
Mountarch Limited
Provensis Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=9903819&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2429674(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Btg International Limited, Anthony David Harman, Paul V. Harper, Neil Pollock, Gary Stewart Sinclair, Mountarch Limited, Provensis Limited filed Critical Btg International Limited
Publication of CA2429674A1 publication Critical patent/CA2429674A1/en
Application granted granted Critical
Publication of CA2429674C publication Critical patent/CA2429674C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/14—Containers or packages with special means for dispensing contents 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
    • B65D83/42—Filling or charging means
    • B65D83/425—Delivery valves permitting filling or charging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Abstract

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 (1) 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.

Claims (32)

1. A method for producing a microfoam suitable for use in scleropathy of blood vessels, characterised in that it 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.
2. A method as claimed in claim l, characterised in that the mixture of blood-dispersible gas and sclerosant liquid is pressurised to a pre-determined level, in the range 800 mbar to 4.5 bar gauge.
3. A method as claimed in claim 2, characterised in that the source of the blood-dispersible gas is removed before the mixture of blood-dispersible gas and sclerosant liquid is released, having pressurised the mixture to a pre-determined level.
4. A method as claimed in any preceding claim, characterised in that the blood-dispersible gas is introduced through the same orifice or lumen as is used for the dispensing of the mixture of blood-dispersible gas and sclerosant liquid.
5. A method as claimed in any preceding claim, characterised in that the physiologically acceptable blood-dispersible gas is introduced into the container holding the aqueous sclerosant liquid on the same day as the foam is to be used in scleropathy of blood vessels.
6. A method as claimed in any preceding claim, characterised in that the sclerosant liquid is stored in the presence of an inert gas or mixture of inert gases.
7. A method as claimed in any preceding claim, characterised in that the blood-dispersible gas is stored in a container provided with engaging means for the container holding the aqueous sclerosant liquid.
8. A method as claimed in any claim 7, characterised in that the engaging means comprises an intermediate element.
9. A method as claimed in claim 8, characterised in that part of the intermediate element is removed before the mixture of blood-dispersible gas and sclerosant liquid is released, having pressurised the mixture to a pre-determined level.
10. A method as claimed in claim 8 or claim 9, characterised in that the intermediate element includes a foaming element to allow the components of the mixture to interact to form a microfoam.
11. A method as claimed in claim 10, characterised in that the foaming element comprises one or more passages of small cross-sectional dimension.
l2. A method as claimed in any preceding claim, characterised in that the mixture is passed through one or more passages having at least one cross-sectional dimension of from 0.1 to 30 µm, 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 a half life of at least 2 minutes.
13. A device for producing a microfoam suitable for use in scleropathy of blood vessels, comprising a housing in which is situated a pressurisable chamber containing a solution of the sclerosing agent in a physiologically acceptable solvent; a pathway with one or more outlet orifices by which the solution may pass from the pressurisable chamber to the exterior of the device through said one or more outlet orifices and a mechanism by which the pathway from the chamber to the exterior can be opened or closed such that, when the container is pressurised and the pathway is open, fluid will be forced along the pathway and through the one or more outlet orifices;
said housing incorporating an inlet for the admission of a pressurised source of physiologically acceptable gas that is dispersible in blood; the gas being in contact with the solution on activation of the mechanism such as to produce a gas-solution mixture;
said pathway to the exterior of the housing including one or more foaming elements;
characterised in that the blood dispersible gas is stored in a container provided with engaging means for the housing holding the aqueous sclerosant liquid.
14. A device as claimed in claim 13, characterised in the foaming elements) comprise one or more passages of cross sectional dimension 0.1 µm to 30 µm, through which the solution and gas mixture is passed to reach the exterior of the device, said passing of said mixture through the passages forming a microfoam of from 0.07 to 0.19 g/ml density and of half life at least 2 minutes.
15. A device as claimed in claim 13 or claim 14, characterised in that the source of the blood-dispersible gas is removed before the mixture of blood-dispersible gas and sclerosant liquid is released, having pressurised the mixture to a pre-determined level.
16. A device as claimed in claim 15, characterised in that the inlet for the admission of physiologically acceptable gas comprises the outlet used for dispensing of the mixture of blood-dispersible gas and sclerosant liquid.
17. A device as claimed in any one of claims 13 to 16, characterised in that the engaging means comprises an intermediate element.
18. A device as claimed in claim 17, characterised in that part of the intermediate element is removable before the mixture of blood-dispersible gas and sclerosant liquid is released, having pressurised the mixture to a pre-determined level.
19. A device as claimed in claim 17 or claim 18, characterised in that the intermediate element includes a foaming element to allow the components of the mixture to interact to form a microfoam.
20. A device as claimed in any one of claims 13 to 19, characterised in that the engaging means comprises a connector which engages at one end with the container for the aqueous sclerosant liquid and at the other end with the container for the blood-dispersible gas.
21. A device as claimed in claim 20, characterised in that the connector comprises a generally cylindrical element with open ends.
22. A device as claimed in claim 20 or 21, characterised in that the connector includes a cam track, whereby rotation of the containers relative to each other moves them together in a controlled fashion.
23. A device as claimed in claim 22, characterised in that the cam track is further provided with a release track, so that the containers may be separated again.
24. A device as claimed in claim 22 or 23, characterised in that one or more detents is provided in the cam track, to enable the user to gauge the progress of the introduction of the blood-dispersible gas.
25. A device as claimed in any one of claims 13 to 24, characterised in that a removable spacer is provided to prevent the containers from being pushed together until required.
26. A device as claimed in claim 25, characterised in that the removable spacer takes the form of an annular collar positioned in between a connector in two parts.
27. A device as claimed in any one of claims 20 to 24, characterised in that the connector includes an aerosol valve actuator mechanism, and the containers may be separated to leave the actuator mechanism attached to the container for the sclerosing agent.
28. A device for producing a microfoam suitable for use in scleropathy of blood vessels, in the form of a kit comprising:

(a) a housing in which is situated a pressurisable chamber containing a solution of the sclerosing agent in a physiologically acceptable solvent; a pathway with one or more outlet orifices by which the solution may pass from the pressurisable chamber to the exterior of the device through said one or more outlet orifices and a mechanism by which the pathway from the chamber to the exterior can be opened or closed such that, when the container is pressurised and the pathway is open, fluid will be forced along the pathway and through the one or more outlet orifices; and (b) a pressurised container containing a physiologically acceptable blood-dispersible gas;
said housing incorporating an inlet for the admission of blood-dispersible gas;
the gas being in contact with the solution on activation of the mechanism such as to produce a gas-solution mixture.
29. A device as claimed in claim 28, characterised in that said pathway to the exterior of the housing includes one or more foaming elements.
30. A device as claimed in any one of claim 28 or claim 29, characterised in that the housing in which is situated the pressurisable chamber containing the solution of the sclerosing agent and the container containing the blood-dispersible gas are placed in a sealed package.
31. A device as claimed in any one of claims 13 to 30, characterised in that the sclerosant liquid is stored in the presence of an inert gas or mixture of inert gases.
32. A method of treating a patient in need of sclerotherapy of a blood vessel comprising administering a microfoam from a device as claimed in any one of claims 13 to 31 to that blood vessel.
CA 2429674 2000-11-24 2001-11-23 Generation of therapeutic microfoam Expired - Lifetime CA2429674C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0028692A GB0028692D0 (en) 2000-11-24 2000-11-24 Generation of therapeutic microform
GB0028692.2 2000-11-24
PCT/GB2001/005186 WO2002041872A1 (en) 2000-11-24 2001-11-23 Generation of therapeutic microfoam

Publications (2)

Publication Number Publication Date
CA2429674A1 true CA2429674A1 (en) 2002-05-30
CA2429674C CA2429674C (en) 2011-10-11

Family

ID=9903819

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2429674 Expired - Lifetime CA2429674C (en) 2000-11-24 2001-11-23 Generation of therapeutic microfoam

Country Status (11)

Country Link
US (3) US20040156915A1 (en)
EP (1) EP1337238B2 (en)
JP (1) JP2004518465A (en)
AT (1) ATE356613T1 (en)
AU (2) AU2388502A (en)
CA (1) CA2429674C (en)
DE (1) DE60127290T3 (en)
ES (2) ES1063053Y (en)
GB (1) GB0028692D0 (en)
WO (1) WO2002041872A1 (en)
ZA (1) ZA200303770B (en)

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WO2002041872A1 (en) 2002-05-30
US20040156915A1 (en) 2004-08-12
ATE356613T1 (en) 2007-04-15
JP2004518465A (en) 2004-06-24
EP1337238A1 (en) 2003-08-27
US7842283B2 (en) 2010-11-30
ES2281465T5 (en) 2017-06-06
AU2002223885B2 (en) 2006-11-23
DE60127290T2 (en) 2007-12-20
GB0028692D0 (en) 2001-01-10
US7842282B2 (en) 2010-11-30
DE60127290D1 (en) 2007-04-26
DE60127290T3 (en) 2017-06-01
CA2429674C (en) 2011-10-11
EP1337238B2 (en) 2017-01-25
ES1063053U (en) 2006-10-01
ES1063053Y (en) 2007-01-01
AU2388502A (en) 2002-06-03
US20070031345A1 (en) 2007-02-08
ES2281465T3 (en) 2007-10-01
EP1337238B1 (en) 2007-03-14
ZA200303770B (en) 2005-02-23
US20070031346A1 (en) 2007-02-08

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