Anatomically shaped vasoocclusive device and method for deploying same

• US 5,766,219 A
• Filed: 02/13/1997
• Issued: 06/16/1998
• Est. Priority Date: 04/20/1995
• Status: Expired due to Term

• Current Assignee: Micrus Corporation (Johnson & Johnson)
• Original Assignee: MUSC Foundation For Research Development (State of South Carolina)
• Inventors: Horton, Joseph A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/799,439
• Time in Patent Office: 488 Days
• Field of Search: 606/191, 606/198, 606/200, 606/151, 606/157, 606/158
• US Class Current: 606/191
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 53/76 about more than one axis , e.g. T-pieces, balls
• CPC Class Codes: B29C 53/821 Mandrels especially adapted for winding and joining
• CPC Class Codes: B29C 61/00 Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor for surface shaping B29C59/18; for lining articles B29C63/38; for joining preformed parts B29C65/66 ; for packaging B65B53/00; connecting arrangements or other fittings for plastics pipes using shrink-down material F16L47/22, electrical connections insulated using heat shrinking insulating sleeves H01R4/72; cable junctions protected by sleeves H02G15/18
• CPC Class Codes: B29K 2029/00 Use of polyvinylalcohols, polyvinylethers, polyvinylaldehydes, polyvinylketones or polyvinylketals or derivatives thereof as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7734 Spherical balls B29L2031/54; globes B29L2022/002
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 77/00 : Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers

Abstract

This invention is an occlusive device for inserting into body cavities or vesicles. More particularly, it is a vasoocclusive device which, as used, is in the approximate shape of an anatomical cavity. It may be ultimately deployed as a substantially spherical shape in the operable configuration. The device is a self-forming shape made from a pre-formed occlusive strand of flexible material. The occlusive strand may be helically coiled or braided and may be adapted with various polymeric fibers. The device is typically introduced through a catheter in the substantially linear inoperable configuration. The invention provides a plurality of such substantially spherical strand portions which nest concentrically with each other in the operable configuration. The invention also includes methods of producing and using the substantially spherical occlusive devices.

Claims

1. A device comprising at least one strand of a flexible material movable between an inoperable substantially linear configuration for insertion into and through a means for delivering the device to a desired portion of a vesicle, and an operable, substantially spherical configuration for occluding at least a portion of said vesicle, said substantially spherical configuration assuming a substantially minimal energy configuration for said strand.

2. The device of claim 1, wherein said strand is helical in shape.

3. The device of claim 2, wherein said flexible material comprises an alloy of titanium and nickel.

4. The device of claim 1, wherein said substantially spherical configuration is substantially hollow.

5. The device of claim 1, further comprising means on the strand for increasing the thrombogenicity of the device.

6. The device of claim 5, wherein said means for increasing the thrombogenicity comprises fibers attached to at least a portion of said strand.

7. The device of claim 1, wherein said flexible material comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and alloys thereof.

8. The device of claim 1, wherein said flexible material comprises an alloy selected from the group consisting of a stainless steel and a super-elastic alloy.

9. The device of claim 1, wherein said strand of flexible material further comprises a first portion and a second portion, said first portion forming a cavity in the substantially spherical configuration, and said second portion being disposed within said cavity.

10. The device of claim 9, wherein said second portion is disposed concentrically within said cavity.

11. The device of claim 9, wherein at least a portion of said second portion of said strand comprises a means for increasing the thrombogenicity of the device.

12. The device of claim 11, wherein said means for increasing the thrombogenicity comprises fibers attached to at least a portion of said strand.

13. The device of claim 9, further comprising a plurality of additional strand portions disposed within said cavity.

14. The device of claim 13, wherein said plurality of additional strand portions are concentrically disposed with each other within said cavity.

15. The device of claim 13, wherein said plurality of additional strand portions are non-concentrically disposed with each other within said cavity.

16. The device of claim 13, wherein at least a portion of said plurality of strand portions comprises fibers attached thereto.

17. A vesicle-occlusion device for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, the device comprising at least one strand of a flexible material having a substantially linear configuration that winds into a substantially spherical configuration for occluding at least a portion of the vesicle, said substantially spherical configuration assuming a substantially minimal energy configuration for said strand.

18. The device of claim 17, wherein said strand is helical in shape.

49. The method of claim 17, further comprising the step of inserting occlusion devices inside of the substantially spherical configuration to increase the thrombogenicity therein.

19. A vesicle-occlusion device for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, the device comprising at least one strand of a flexible material having a substantially linear configuration that winds into a three-dimensional configuration approximating the shape of the vesicle into which the device is inserted to occluding at least a portion of the vesicle, said three-dimensional configuration assuming a substantially minimal energy configuration for said strand.

20. The device of claim 19, wherein said three-dimensional configuration is formed of overlapping loops of said strand crossing upon itself.

21. The device of claim 19, wherein said strand is helical in shape.

22. A vesicle-occlusion device for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, the device comprising at least one strand of a flexible material having a substantially linear configuration that winds into a three-dimensional cage within the vesicle for occluding at least a portion of the vesicle, said three-dimensional cage assuming a substantially minimal energy configuration for said strand.

23. The device of claim 22, wherein said three-dimensional cage is formed of overlapping layers of said strand crossing upon itself.

24. The device of claim 23, wherein overlapping layers of said three-dimensional cage form a predetermined lattice configuration sufficient to retain a smaller vesicle-occlusion device within said three-dimensional cage.

25. The device of claim 22, wherein said strand is helical in shape.

26. A device comprising at least one strand of a flexible material movable between an inoperable substantially linear configuration for insertion into and through a means for delivering the device to a desired portion of a vesicle, and an operable, substantially spherical configuration for occluding at least a portion of said vesicle, said substantially spherical configuration having about 90% of said strand in about the outer 15% of the diameter of said substantially spherical configuration.

27. The device of claim 26, wherein said strand is helical in shape.

28. The device of claim 27, wherein said flexible material comprises an alloy of titanium and nickel.

29. The device of claim 26, wherein said substantially spherical configuration is substantially hollow.

30. The device of claim 26, further comprising means on the strand for increasing the thrombogenicity of the device.

31. The device of claim 30, wherein said means for increasing the thrombogenicity comprises fibers attached to at least a portion of said strand.

32. The device of claim 26, wherein said flexible material comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and alloys thereof.

33. The device of claim 26, wherein said flexible material comprises an alloy selected from the group consisting of a stainless steel and a super-elastic alloy.

34. The device of claim 26, wherein said strand of flexible material further comprises a first portion and a second portion, said first portion forming a cavity in the substantially spherical configuration, and said second portion being disposed within said cavity.

35. The device of claim 34, wherein said second portion is disposed concentrically within said cavity.

36. The device of claim 34, wherein at least a portion of said second portion of said strand comprises a means for increasing the thrombogenicity of the device.

37. The device of claim 36, wherein said means for increasing the thrombogenicity comprises fibers attached to at least a portion of said strand.

38. The device of claim 34, further comprising a plurality of additional strand portions disposed within said cavity.

39. The device of claim 38, wherein said plurality of additional strand portions are concentrically disposed with each other within said cavity.

40. The device of claim 38, wherein said plurality of additional strand portions are non-concentrically disposed with each other within said cavity.

41. The device of claim 38, wherein at least a portion of said plurality of strand portions comprises fibers attached thereto.

42. A vesicle-occlusion device for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, the device comprising at least one strand of a flexible material having a substantially linear configuration that winds into a substantially spherical configuration for occluding at least a portion of the vesicle, said substantially spherical configuration having about 90% of said strand in about the outer 15% of the diameter of said substantially spherical configuration.

43. The device of claim 42, wherein said strand is helical in shape.

44. A vesicle-occlusion device for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, the device comprising at least one strand of a flexible material having a substantially linear configuration that winds into a three-dimensional configuration approximating the shape of the vesicle into which the device is inserted to occlude at least a portion of the vesicle, said three-dimensional configuration having about 90% of said strand in about the outer 15% of the diameter of said three-dimensional configuration.

45. The device of claim 44, wherein said three-dimensional configuration is formed of overlapping layers of said strand crossing upon itself.

46. The device of claim 45, wherein said overlapping layers of said three-dimensional configuration form a predetermined lattice configuration sufficient to retain a smaller vesicle-occlusion device within said three-dimensional cage.

47. The device of claim 44, wherein said strand is helical in shape.

48. A method for repairing a vessel having a vesicle to restore physiologically normal flow to the vessel, comprising the steps of:

moving a catheter through the vessel and to the vesicle;

moving through said catheter a vesicle-occlusion device comprising at least one strand of a flexible material movable between an inoperable substantially linear configuration for insertion into and through said catheter, and an operable, substantially spherical configuration for occluding at least a portion of said vesicle; and

delivering said device from said catheter and into the vesicle to form said substantially spherical configuration for occluding at least a portion of the vesicle, said substantially spherical configuration assuming a substantially minimal energy configuration for said strand.