Polyvinyl alcohol microspheres, injectable solutions and therapeutic uses of the same
View Patent ↗The present invention relates to microspheres useful for embolization which comprises polyvinylalcohol. The present invention also relates to an injectable suspension suitable for embolization which comprises the polyvinylalcohol microspheres and a suitable liquid carrier. The present invention further relates to a method for prophylactic or therapeutic embolization which comprises administering to a mammal an injectable suspension containing the polyvinylalcohol microspheres and a suitable liquid carrier. Finally, the present invention relates to a process for producing the polyvinylalcohol microspheres.
1. Microspheres useful for embolization, wherein said microspheres comprise crosslinked polyvinyl alcohol, have a diameter ranging from about 50 μm to about 1,000 μm, and are substantially spherical and sterile, wherein the difference in diameter between the microspheres is from about 0 μm to about 150 μm, wherein the microspheres comprise from about 0.5% to about 20% polyvinyl alcohol by weight in hydrogel form.
2. The microspheres of claim 1 , wherein said microspheres further comprise a cell adhesion promoter.
3. The microspheres of claim 1 , wherein said microspheres further comprise a marking agent.
4. The microspheres of claim 3 , wherein the marking agent is selected from the group consisting of a dye, an imaging agent and a contrasting agent.
5. The microspheres of claim 1 , further comprising an anti-angiogenic agent.
6. The microspheres of claim 1 , wherein the microspheres are substantially uniform in size.
7. The microspheres of claim 1 , wherein the microspheres are substantially uniform in shape.
8. Microspheres useful for embolization, wherein said microspheres comprise crosslinked polyvinyl alcohol, have a diameter ranging from about 10 μm to about 2,000 μm, and are substantially spherical and sterile, wherein the microspheres comprise from about 0.5% to about 20% polyvinyl alcohol by weight in hydrogel form, wherein the surface of the microspheres appears smooth under less than 1000-fold magnification and said microspheres do not aggregate by surface interaction, and wherein the microspheres are configured to occlude blood flow through a vessel when positioned in the vessel.
9. An injectable sterile suspension comprising the microspheres of claim 1 and a suitable liquid carrier.
10. A kit comprising the microspheres of claim 1 .
11. A method for the treatment of a cancer or tumor in a mammal by embolization, comprising administering to the mammal an effective amount of the microspheres of claim 1 .
12. The method of claim 11 , wherein the cancer or tumor is a hepatocellular carcinoma, liver metastases, uterine tumor, uterine fibroid, colorectal cancer, bone metastases, melanomas, cancer of the head, cancer of the neck, or intracranial meningioma.
13. A method for the treatment of a small intestinal hemorrhage in a mammal by embolization, comprising administering to the mammal an effective amount of the microspheres of claim 1 .
14. A method for the treatment of a vascular malformation in a mammal by embolization, comprising administering to the mammal an effective amount of the microspheres of claim 1 .
15. The method of claim 14 , wherein the vascular malformation is an arteriovenous malformation (AVM).
16. The microspheres of claim 2 , wherein the cell adhesion promoter is selected from at least one of the following: carboxymethyl (CM) dextran, collagen, DEAE dextran, gelatin, glucosaminoglycans, fibronectin, lectins, and polycations.
17. The microspheres of claim 16 , wherein the cell adhesion promoter is selected from at least one of the following: carboxymethyl (CM) dextran, collagen, and DEAE dextran.
18. The microspheres of claim 8 , wherein the difference in diameter between the microspheres is from about 0 μm to about 150 μm.