# US 10,441,539 B2 · Devices and methods for injectable vascular sclerofoams using a carrier matrix and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,539 B2 - Document ID: US10441539B2 - Status: Granted - Kind: B2 - Application number: 15/323,573 - Filed: 2015-07-02 - Published: 2017-06-08 - Granted: 2019-10-15 - Earliest claimed: 2014-07-03 - Assignees: Swiss VX Venentherapie Und Forschung GMBH - Applicants: Swiss Vx Venentherapie Und Forschung GmbH - Inventors: Johann Christof Ragg - Web page: https://patentgrep.com/patent/US10441539B2 ## CPC - A61K 9/122: {Foams; Dry foams (edible foams A61K9/0056)} - 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)} - A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates - A61K 31/08: acyclic, e.g. paraformaldehyde - A61K 31/185: Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids (hydroxamic acids A61K31/16; peroxy acids A61K31/327) - A61K 31/255: of sulfoxy acids or sulfur analogues thereof - A61K 31/45: having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide - A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42) - A61P 9/00: Drugs for disorders of the cardiovascular system - A61P 9/14: Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The invention relates in particular to an injectable sclerosant drug foam comprising: (i) a matrix; (ii) at least one fluid; (iii) at least one sclerosant drug; (iv) a medical gas or medical gas mixture acceptable for intravenous use, (v) wherein said matrix has physical properties, which are comparable to denatured blood, wherein the denatured blood is obtainable from a fresh human venous whole blood sample of 1 ml volume, which is heated in a cylindrical polyethylene container with 3 mm inner diameter and 3.4 mm outer diameter for about 0.5 min. to about 10 min. at a temperature of about between 70° C. and 100° C. and/or (vii) said level of denaturation is defined by the change of red-colored hemoglobin to brown as an indicator, wherein Fe2+ is reduced to Fe3+ in the hemoglobin complex to a degree of at least 80%, preferably 90% and even more preferably 95%. ## Claims ### Claim 1 An injectable sclerosant drug foam comprising: (i) a matrix; (ii) at least one fluid; (iii) at least one sclerosant drug; and (iv) a medical gas or medical gas mixture acceptable for intravenous use, wherein said matrix has physical properties comparable to denatured blood, wherein the denatured blood was denatured as follows: a fresh human venous whole blood sample of 1 ml volume is heated in a cylindrical polyethylene container with an inner diameter of 3 mm and an outer diameter of 3.4 mm for about 0.5 min. to about 10 min. at a temperature of about between 70° C. and 100° C. ### Claim 2 (depends on 1) The sclerosant drug foam of claim 1, wherein the matrix comprises denatured blood. ### Claim 3 (depends on 2) The sclerosant drug foam of claim 2, wherein the denatured blood is dispersed in a pharmaceutically acceptable liquid and optionally wherein the pharmaceutically acceptable liquid is the sclerosant drug or the sclerosant drug is dissolved or dispersed in the pharmaceutically acceptable liquid. ### Claim 4 (depends on 1) The sclerosant drug foam of claim 1, wherein the denatured blood is autologous blood of the respective patient. ### Claim 5 (depends on 1) The sclerosant drug foam of claim 1, wherein blood has been denatured by chemical means, heat, or radiation, wherein said radiation is an electromagnetic radiation. ### Claim 6 (depends on 1) The sclerosant drug foam of claim 1, wherein at least one sclerosant drug is selected from the group consisting of sodium tetradecyl sulfate, ethanol, or polidocanol. ### Claim 7 (depends on 1) The sclerosant drug foam of claim 1, wherein the dispersed partially denatured blood has a maximum solid particle size of 5-300 μm. ### Claim 8 (depends on 1) The sclerosant drug foam of claim 1, wherein the foam has a bubble size of 10-300 μm. ### Claim 9 (depends on 1) A method for producing the sclerosant drug foam of claim 1 comprising the steps of: (a) providing a matrix, wherein said matrix has physical properties comparable to denatured blood, wherein the denatured blood was denatured as follows: a fresh human venous whole blood sample of 1 ml volume is heated in a cylindrical polyethylene container with an inner diameter of 3 mm and an outer diameter of 3.4 mm for about 0.5 min. to about 10 min. at a temperature of about between 70° C. and 100° C.; (b) providing at least one pharmaceutically acceptable liquid and at least one sclerosant drug; (c) dispersing the matrix at a temperature of between 10° C. and 77° C. in the pharmaceutically acceptable liquid, wherein the pharmaceutically acceptable liquid comprises said at least one sclerosant drug; and (d) foaming the dispersion with medical a gas suitable for intravenous use wherein the medical gas is selected form O2, CO2 or mixtures thereof. ### Claim 10 (depends on 1) A method of treating venous insufficiency using a sclerosant drug foam comprising the steps of (i) establishing an access to one or several target veins by use of canulas, microcatheters or catheters, and optionally taking of at least one autologous blood sample; (ii) preparing a sclerosant drug foam of claim 1; (iii) injecting the sclerosant drug foam into the target veins preferably using ultrasound monitoring; and (iv) removing the canulas, microcatheters, or catheters previously used to establish an access to the target veins.