Foam matrix embolization device
The present invention relates to a medical device for placement at a predetermined location within a passageway of the human body, and more particularly, relates to a flexible embolization device which may be delivered by a catheter to a pre-selected position within a blood vessel to thereby embolize a blood vessel or a blood vessel defect, such as an aneurysm or fistula. Specifically, the embolization device comprises an elongated coil having a lumen, the coil and lumen being at least partially embedded in an elongated foam member comprising, in some embodiments, a flexible, biodegradable, water insoluble, open, interconnecting-cell foam material having embolic characteristics, and capable of allowing cell proliferation into the open cell foam interior.
1. A vascular embolization device adapted for delivery to a position within a patient's blood vessel comprising an elongated coil having a lumen, said coil and lumen prior to said delivery being at least partially embedded in an elongated foam member comprising a flexible, biodegradable, open and interconnecting cell foam material having embolic characteristics, and capable of allowing cell proliferation into the open cell foam interior, the foam member having an average pore size of 5-100 microns, said elongated foam member having an outer diameter which, in uncompressed condition, is no more than 0.006 inch greater than the outer diameter of the elongated coil.
2. The device of claim 1 in which the uncompressed, outer diameter of the elongated foam member is no more than about 0.004 inch greater than the outer diameter of the elongated coil.
3. The device of claim 1 in which the uncompressed, outer diameter of said foam member is no more than about 0.016 inch, and the outer coil diameter is about 0.01-0.014 inch.
4. The device of claim 1 in which the lumen of the coil is filled with said foam member.
5. The device of claim 1 in which the foam member comprises a polymer formulation that is flexible and cohesive, with or without the presence of water.
6. The device of claim 1 in which the foam member is elastomeric.
7. The device of claim 1 in which substantially the entire length of said elongated coil is embedded in the elongated foam member.
8. The device of claim 1 in which the foam member comprises a PCL/PGA copolymer.
9. The device of claim 8 in which the lumen of the coil is filled with said foam member.