Polymer covered vaso-occlusive devices and methods of producing such devices

• US 6,280,457 B1
• Filed: 06/04/1999
• Issued: 08/28/2001
• Est. Priority Date: 06/04/1999
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Wallace, Michael P., Hui, Delilah Yin
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US09/326,188
• Time in Patent Office: 816 Days
• Field of Search: 604/191, 604/192, 604/108, 604/107, 604/200
• 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 17/12113 within an aneurysm
• 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 17/12154 having stretch limiting means
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable

Abstract

This is a medical device for forming an embolism within the vasculature of a patient. More particularly, it concerns an occlusion device comprising an inner core covered with a polymer. The medical device encourages cellular attachment and growth while maintaining favorable handling, deployment and visualization characteristics.

Claims

1. A vaso-occlusive device comprising a wire having an outer circumferential surface and formed into a helically wound primary shape and at least one polymeric fiber substantially covering the device wherein said at least one polymeric fiber is wrapped around and onto the circumferential surface of said wire over a substantial portion thereof.

2. The vaso-occlusive device of claim 1 where said at least one polymeric fiber is helically wound about the wire.

3. The vaso-occlusive device of claim 2 where the fiber is wound about the wire with a closed pitch.

4. The vaso-occlusive device of claim 2 where the fiber is wound about the wire with an open pitch.

5. The vaso-occlusive device of claim 1 where said polymeric covered wire is radiopaque.

6. The vaso-occlusive device of claim 5 where the polymeric fiber further comprises a radiopaque additive.

7. The vaso-occlusive device of claim 5 where the wire is radiopaque.

8. The vaso-occlusive device of claim 1 further having a detachable tip.

9. The vaso-occlusive device of claim 8 where said detachable tip is an electrolytically severable joint attached to the device, said electrolytically severable joint being relatively more susceptible to electrolysis in an ionic solution than is the device, wherein the device is electrically isolated from said electrolytically severable joint.

10. The vaso-occlusive device of claim 1 where said polymeric covered wire has a secondary shape.

11. The vaso-occlusive device of claim 10 where said secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortex-shaped, ovoid, randomly shaped, and substantially spherical.

12. The vaso-occlusive device of claim 1 where the fiber comprises a mono-filament.

13. The vaso-occlusive device of claim 1 where the fiber comprises multi-filament comprised of a plurality of filaments.

14. The vaso-occlusive device of claim 10 further comprising a stretch-resisting member having a first end and a second end, the stretch-resisting member extending through at least a portion of an interior of said primary shape, said stretch-resisting member not substantially affecting the shape of said coil when said coil is in said secondary shape, and said stretch-resisting member being attached to said coil in at least two locations.

15. A method for making a vaso-occlusive device, comprising:

a) winding at least one polymeric fiber around and onto circumferential surface of a wire over a substantial portion thereof; and

b) shaping the polymer wrapped wire of step (a) into a primary shape.

16. The method of claim 15 further shaping the polymeric covered wire into a secondary shape.

17. The method of claim 16 where the secondary shape is shaped by pulling a stylet through the primary shape of the polymeric covered wire.

18. The method of claim 16 wherein the secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortex-shaped, ovoid, randomly shaped, spherical shaped, and substantially spherical.

19. The method of claim 15 wherein the primary shape comprises an elongated helical coil.

20. The method of claim 15 wherein the primary shape is a cylindrical helical coil.

21. The method of claim 15 wherein the wire comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, and alloys thereof.

22. The method of claim 15 wherein the polymeric fiber is selected from the group consisting of protein-based polymers, absorbable polymers, and non-protein based polymers.

23. The method of claim 15 where the polymeric fiber comprises a mono-filament.

24. The method of claim 15 where the polymeric fiber comprises a multi-filament comprised of a plurality of filaments.

25. The product made by the method of claim 15.

39. A method of at least partially occluding an aneurysm comprising:

a) making a polymer covered coil according to the method of claim 25; and

b) deploying the polymer covered coil into the aneurysm.

40. The method of claim 39, wherein the polymer covered coil includes an electrolytically detachable tip and is deployed using an electrical current.

41. The method of claim 39, wherein the polymer wrapper coil includes a mechanically detachable tip and is deployed using a mechanical detachment.

26. A method for making a vaso-occlusive device, comprising:

a) shaping a wire into a primary shape;

b) winding at least one polymeric fiber about a mandrel;

c) applying heat to the at least one polymeric fiber;

d) removing the at least one polymeric fiber from the mandrel; and

e) attaching the at least one polymeric fiber about the primary shape of the wire.

27. The method of claim 26 further comprising the step of heating the wire to further shape the wire into a secondary shape prior to the step of attaching the at least one polymeric fiber about the primary shape of the wire.

28. The method of claim 26 further shaping the polymeric covered device into a secondary shape.

29. The method of claim 26 where the secondary shape is shaped by pulling a stylet through the primary shape of the polymeric covered wire.

30. The method of claim 26 further heating the polymeric covered wire.

31. The method of claim 26 wherein the primary shape comprises an elongated helical coil.

32. The method of claim 26 wherein the primary shape is a cylindrical helical coil.

33. The method of claim 26 wherein the wire comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, and alloys thereof.

34. The method of claim 26 wherein the polymeric fiber is selected from the group consisting of protein-based polymers, bio-absorbable polymers, and non-protein based polymers.

35. The method of claim 26 wherein the secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortex-shaped, ovoid, randomly shaped, and substantially spherical.

36. The method of claim 26 where the polymeric fiber comprises a mono-filament.

37. The method of claim 26 where the polymeric fiber comprises a multi-filament comprised of a plurality of filaments.

38. The product made by the process of claim 26.

42. A vaso-occlusive device comprising a wire shaped into a helical primary form, said primary form defining a outer circumferential surface and wherein a non-woven biodegradable polymeric fiber is wrapped onto and around the circumferential surface over a substantial portion thereof.

43. The vaso-occlusive device of claim 42 where the polymeric fiber is heated.

44. The vaso-occlusive device of claim 42 further having a detachable tip.

45. The vaso-occlusive device of claim 42 where said detachable tip is an electrolytically severable joint attached to the device, said electrolytically severable joint being relatively more susceptible to electrolysis in an ionic solution than is the device, wherein the device is electrically isolated from said electrolytically severable joint.

46. The vaso-occlusive device of claim 42 where said primary shape is a substantially helical coil.

47. The vaso-occlusive device of claim 46 where said polymeric covered wire has a secondary shape.

48. The vaso-occlusive device of claim 47 where said secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortex-shaped, ovoid, randomly shaped, and substantially spherical.

49. The vaso-occlusive device of claim 42 where the fiber comprises a mono-filament.

50. The vaso-occlusive device of claim 47 where the fiber comprises multi-filament comprised of a plurality of filaments.

51. The vaso-occlusive device of claim 47 further comprising a stretch-resisting member having a first end and a second end, the stretch-resisting member extending through at least a portion of an interior of said primary shape, said stretch-resisting member not substantially affecting the shape of said coil when said coil is in said secondary form, and said stretch-resisting member being attached to said coil in at least two locations.

52. The vaso-occlusive device of claim 42 where the biodegradable polymer is comprised of at least one polymer selected form group consisting of:

lactide, glycolide, and caprolactone polymers and their copolymers;

hydroxybutyrate and polyhydroxyvalerate and their block and random copolymers;

a polyether ester;

anhydrides, polymers and copolymers of sebacic acid, hexadecandioic acid; and

orthoesters.

53. The vaso-occlusive device of claim 52 where the biodegradable polymer comprises polydioxinone.

54. The vaso-occlusive device of claim 42 where the biodegradable polymer is comprised of at least one polymer selected from the group consisting of:

polyglycolic and polylactic acids, their block and random copolymers.