IMPLANT INCLUDING A COIL AND A STRETCH-RESISTANT MEMBER

• US 20080228215A1
• Filed: 02/27/2008
• Published: 09/18/2008
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Hewitt, Todd Jeffrey, Divino, Vince, Vu, Khoa Dang, Brennan, Scott William, Patterson, William Robert, Strauss, Brian Michael, Faught, Stacy Leon, Carrillo, Ramon Torres, Wilbur, Larry
• Granted Patent: US 8,328,860 B2
• Time in Patent Office: Days
• 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 17/12113 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 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12059 Joint of soluble material
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61B 2017/12081 detachable by inflation
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

This invention is directed to implantable coils and, more particularly, to a coil implant having a stretch-resistant member internal to the coil. The implant of the invention is able to freely articulate and torque prior to delivery. Once delivered, the implant is no longer stretch resistant and is therefore able to substantially conform to the vascular site.

Claims

1. An implant, comprising:

a primary coil defining a lumen disposed along an axis, the primary coil having a proximal end defining a proximal aperture and a distal end defining a distal aperture;

a stretch-resistant member disposed within the lumen;

a member having a central axis that intersects the proximal aperture, the member being coupled to the stretch-resistant member within the lumen, and having an engagement portion exterior the lumen wherein said engagement portion and said member are capable of moving distally into the lumen; and

a retainer engaging the distal aperture and coupled to the stretch-resistant member within the lumen.

2. The implant of claim 1, wherein the engagement portion and member is capable of moving distally completely into the lumen.

3. The implant of claim 1 further comprising

a secondary coil further defining the proximal aperture which coil is coaxial with the primary coil and having a distal end and proximal end.

4. The implant of claim 3, wherein the primary coil has an outer and an inner diameter and the secondary coil has an outer diameter which is smaller than or equal to the inner diameter of the primary coil.

5. The implant of claim 3, wherein the proximal end of the primary coil is adjacent to or partially envelopes the distal end of the secondary coil.

6. The implant of claim 3, wherein the primary coil and the secondary coil are independently comprised of a metal wire.

7. The implant of claim 6, wherein the wire is comprised of a metal selected from the group consisting of platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten, tantalum, an alloy of two or more of these metals, or a super elastic metal.

8. The implant of claim 7, wherein the wire is a platinum alloy.

9. The implant of claim 3, wherein the primary coil and the secondary coil is comprised of a primary helix which is itself wound and set into a secondary shape.

10. The implant of claim 9, wherein the secondary shape is selected from helical, spheroidal, cubic, and tertiary space-filling shapes.

11. The implant of claim 1, wherein the stretch-resistant member is comprised of a polymer.

12. The implant of claim 11, wherein the polymer is biodegradable or non-biodegradable.

13. The implant of claim 12, wherein the polymer is polypropylene.

14. The implant of claim 11, wherein the stretch-resistant member is further comprised of a bioactive coating.

15. The implant of claim 14, wherein the bioactive coating is selected from the group consisting of a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a monosaccharide, a disaccharide, a polysaccharide, collagen and combinations thereof.

16. The implant of claim 1, further comprising

a plurality of fibers.

17. The implant of claim 16, wherein the fibers are wrapped around the primary and/or secondary coil at least one time.

18. The implant of claim 16, wherein each fiber is wrapped around the stretch resistant member at least one time.

19. The implant of claim 17 or claim 18, wherein each fiber is wrapped around at least two times.

20. The implant of claim 16, wherein the fibers are comprised of a copolymer of glycolic acid and lactic acid.

21. The implant of claim 20, wherein the fibers further comprise a bioactive coating.

22. The implant of claim 21, wherein the coating is either a lubricious hydrophilic coating and a hydrophobic coating.

23. The implant of claim 21, wherein the coating comprises a copolymer of lactic acid and glycolic acid.

24. The implant of claim 16, wherein the fibers are comprised of a biodegradable polymer.

25. The implant of claim 24, wherein the biodegradable polymer is selected from the group consisting of polyglycolic acid, polycaprolactone, polyhydroxybutyrate valearte, polyorthoester, polylactic acid, poly(p-dioxanone), poly(valerolactone), poly(tartronic acid), poly(β

-malonic acid), poly(propylene fumarate), poly(anhydrides), and tyrosine-based polycarbonates.

26. The implant of claim 25, wherein the polymer is polyglycolic acid and polylactic acid and is present in a ratio of polyglycolic acid and polylactic acid selected from 99:

1;

95;

5, 90;

10, 50;

50, 10;

90, 5;

95, or 1;

99.

27. The implant of claim 1, wherein the retainer has a portion that is exterior the lumen of the primary coil.

28. The implant of claim 27, wherein the portion that is exterior has a shape that is rounded.

29. The implant of claim 1, wherein the retainer is comprised of a polymer.

30. The implant of claim 29, wherein the polymer is polypropylene.

31. The implant of claim 1, wherein the distal portion of the member having a central axis that intersects the proximal aperture comprises an eyelet.

32. The implant of claim 31, wherein the stretch resistant member is coupled to the eyelet with a knot.

33. The implant of claim 32, where in the knot is a half-hitch or a hitch knot.

34. The implant of claim 1, wherein the engagement portion is disengageable from a positioner by chemical detachment, electrolytic detachment, mechanical detachment, hydraulic detachment, or thermal detachment.

35. A method of embolizing a vascular site in a patient, comprising introducing to said site via a positioner an implant comprising

a primary coil defining a lumen disposed along an axis, the primary coil having a proximal end defining a proximal aperture and a distal end defining a distal aperture;

a stretch-resistant member disposed in the lumen;

a retainer engaging the distal aperture and coupled to the stretch-resistant member within the lumen; and

a member having a central axis that intersects the proximal aperture at various points, the member being coupled to the stretch-resistant member within the lumen, and having an engagement portion exterior the lumen said member is capable of moving distally into the lumen;

thereby embolizing the vascular site.

36. The method of claim 35, wherein the implant substantially conforms to the vascular site.

37. The method of claim 35, wherein the positioner is a microcatheter.

38. The method of claim 35, further comprising detaching said implant from the positioner.

39. The method of claim 38, wherein the implant is detached by either chemical detachment, electrolytic detachment, mechanical detachment, hydraulic detachment, or thermal detachment.

40. The method of claim 38, wherein after detachment, the member and engagement portion is free to move within the lumen.

41. The method of claim 40, wherein after detachment the engagement portion and member is contained in the lumen.

42. The method of claim 41 wherein the engagement portion is completely contained in the lumen.

43. The method of claim 38, wherein the implant is stretch-resistant prior to detaching from the positioner.

44. The method of claim 43, wherein the implant is no longer stretch-resistant after detaching from the positioner.

45. The method of claim 38, further comprising

delivering additional implants.