Foam matrix embolization device

• US 20060058834A1
• Filed: 11/18/2005
• Published: 03/16/2006
• Est. Priority Date: 09/18/2000
• Status: Active Grant

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Mitelberg, Vladimir, Jones, Donald K., Davis, Richard Champion III, Sherman, Darren R., Vyakarnam, Murty, Lorenzo, Juan A., Do, Hiep Q.
• Granted Patent: US 8,313,504 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

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.

Claims

1. A vascular embolization device comprising an elongated coil having a lumen, said coil and lumen being at least partially embedded in an elongated foam member comprising a biodegradable, open and interconnecting-cell foam material.

2. The device of claim 1 in which the elongated foam member has an outer diameter which, in uncompressed condition, is no more than about 0.006 inch greater than the outer diameter of the elongated coil.

3. 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.

4. The device of claim 1 in which the uncompressed, outer diameter of said elongated foam member is no more than about 0.016 inch, and the outer coil diameter is about 0.01-0.014 inch.

5. The device of claim 1 in which the lumen of the coil is filled with said foam member.

6. 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.

7. The device of claim 1 in which the foam member is elastomeric.

8. The device of claim 1 in which substantially the entire length of said elongated coil is embedded in the elongated foam member.

9. The device of claim 1 in which said elongated coil is made of a material comprising platinum.

10. The device of claim 1 in which the elongated foam member has an average pore size of 5-500 microns.

11. The device of claim 1 in which the foam material comprises a PCL/PGA copolymer.

12. A vascular embolization device comprising an elongated coil having a lumen, said coil and lumen 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.

13. The device of claim 12 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.

14. The device of claim 12 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.

15. The device of claim 12 in which the lumen of the coil is filled with said foam member.

16. The device of claim 12 in which the foam member comprises a polymer formulation that is flexible and cohesive, with or without the presence of water.

17. The device of claim 12 in which the foam member is elastomeric.

18. The device of claim 12 in which substantially the entire length of said elongated coil is embedded in the elongated foam member.

19. The device of claim 12 in which the foam member comprises a PCL/PGA copolymer.

20. The device of claim 19 in which the lumen of the coil is filled with said foam member.

21. A vascular embolization system for treating a defect in a blood vessel comprising:

a catheter having a proximal section, a distal section and an outer wall defining a lumen therethrough;

a pusher member slidably disposed within the lumen of said catheter having a proximal end and a distal end; and

,

an embolization device comprising an elongated coil and an elastomeric foam disposed about said coil, said foam having a porous structure and having an outer diameter smaller than the lumen of said catheter;

wherein said embolization device is disposed within the lumen at the distal section of said catheter, the distal end of said pusher member engages the embolization device such that distal movement of the pusher member causes the embolization device to exit the lumen of the catheter at a pre-selected position within the blood vessel.

22. A vascular embolization system as defined in claim 21, wherein said embolization device takes a convoluted shape.

23. A vascular embolization system as defined in claim 21, wherein said embolization device is comprised of a radiopaque material.

24. A vascular embolization system as defined in claim 21, wherein said embolization device is comprised of a therapeutic agent.

25. A vascular embolization system as defined in claim 21, wherein said elastomeric foam has an outer diameter which, is no more than about 0.006 inch greater than the outer diameter of the elongated coil.

26. A vascular embolization system as defined in claim 21, wherein said elastomeric foam extends within the lumen of said elongate coil.

27. A vascular embolization system for treating a defect in a blood vessel comprising:

a catheter having a proximal section, a distal section and an outer wall defining a lumen therethrough;

a pusher member slidably disposed within the lumen of said catheter having a proximal end and a distal end; and

,

an embolization device comprising a foam member, said foam having a porous structure and having an outer diameter smaller than the lumen of said catheter;

wherein said embolization device is disposed within the lumen at the distal section of said catheter, the distal end of said pusher member engages the embolization device such that distal movement of the pusher member causes the embolization device to exit the lumen of the catheter at a pre-selected position within the blood vessel.

28. A vascular embolization system as defined in claim 27, wherein said embolization device takes a convoluted shape.

29. A vascular embolization system as defined in claim 27, wherein said embolization device is comprised of a radiopaque material.

30. A vascular embolization system as defined in claim 27, wherein said embolization device is comprised of a therapeutic agent.

31. A vascular embolization system as defined in claim 27, wherein said embolization device is comprised of an embolic coil.

32. A vascular embolization system as defined in claim 31, wherein said foam has an outer diameter which, is no more than about 0.006 inch greater than the outer diameter of the elongated coil.

33. A vascular embolization system as defined in claim 31, wherein said foam extends within the lumen of said elongate coil.

34. A vascular embolization system for treating a defect in a blood vessel comprising:

a catheter having a proximal section, a distal section and an outer wall defining a lumen therethrough;

a pusher member slidably disposed within the lumen of said catheter having a proximal end and a distal end; and

,

an embolization device comprising an elongated coil and an elastomeric foam disposed about said coil, said foam having a porous structure;

wherein said embolization device is disposed within the lumen at the distal section of said catheter, the distal end of said pusher member engages the embolization device such that distal movement of the pusher member causes the embolization device to exit the lumen of the catheter at a pre-selected position within the blood vessel.

35. A vascular embolization system as defined in claim 34, wherein said embolization device takes a convoluted shape.

36. A vascular embolization system as defined in claim 34, wherein said embolization device is comprised of a radiopaque material.

37. A vascular embolization system as defined in claim 34, wherein said embolization device is comprised of a therapeutic agent.

38. A vascular embolization system as defined in claim 34, wherein said elastomeric foam has an outer diameter which, is no more than about 0.006 inch greater than the outer diameter of the elongated coil.

39. A vascular embolization system as defined in claim 34, wherein said elastomeric foam extends within the lumen of said elongate coil.