Vaso-occlusion coil and method

• US 4,994,069 A
• Filed: 11/02/1988
• Issued: 02/19/1991
• Est. Priority Date: 11/02/1988
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Sepetka, Ivan, Engelson, Erik, Ritchart, Mark, Mariant, Mike
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Prebilic, Paul
• Application Number:
  US07/265,908
• Time in Patent Office: 839 Days
• Field of Search: 606/194, 606/198, 606/200, 606/191, 604/104, 623/1, 623/11, 623/12
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A flexible, preferably coiled wire for use in small-vessel vaso-occlusion. The wire has a stretched, linear condition in which it can be advanced through a catheter lumen to a selected vessel, and a relaxed, convoluted condition produced by a combination of a helical winding of the wire, and irregularities of the helical winding. When the wire is released from a catheter into a vessel, it assumes a randomly coiled, substantially space-filling mass which is lodged at the site of release. In a preferred embodiment, the helical winding in the wire'"'"'s relaxed condition has about the same diameter as that of the vessel, and the wire, in its stretched condition, has a length of about 15-20 times the vessel diameter.

Claims

1. A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by:

(a) a relaxed condition in which the wire assumes a folded, convoluted conformation which is adapted to form a substantially space-filling body having a substantially predetermined diameter when the wire is in said released condition,

(b) a stretched condition in which the wire has a linear conformation in which the wire can be pushed through said catheter, and

(c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

2. The wire of claim 1, which, in its stretched condition, is an elongate helically coiled wire formed by wrappings of a metal thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-filling body formed when the wire is in said relaxed condition.

3. The wire of claim 2, wherein the diameter of the coil is between about 10-30 mils and the metal thread is platinum, tungsten, or gold.

4. The wire of claim 1, which is formed of a shape-memory polymer.

5. The wire of claim 4, which is formed of a tubular polymer, and the tube contains a drug intended for slow release.

6. The wire of claim 4, wherein the polymer is coated with a drug that is released slowly from the polymer within a vessel site.

7. The wire of claim 2, whose relaxed conformation is characterized by a helical windings of the coiled wire, and a tertiary structure formed by irregular bends in the winding.

8. The wire of claim 7, wherein the diameter of the helical winding is substantially the same as that of the vessel to be occluded.

9. The wire of claim 7, wherein the irregularities in the helical winding take the form of angular offsets in the helical axis.

10. The wire of claim 7, wherein the helical winding has a spiral shape dimensioned to fill the cross sectional area of the vessel to be occluded.

11. The wire of claim 7, wherein the diameter of the coil is between about 10-30 mils, the diameter of the secondary coiled conformation is substantially the same as that of the vessel to be occluded and the metal thread forming the wire is platinum, gold, or tungsten.

12. The wire of claim 11, for occlusion of a 0.5-2 mm diameter vessel, wherein the length of the wire, in its stretched condition, is about 3-6 cm.

13. The wire of claim 11, for occlusion of a vessel about 3-6 mm in diameter, wherein the length of the wire, in its stretched condition, is about 4-9 cm.

14. A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by:

(a) a stretched, substantially linear condition in which the wire can be pushed through the catheter;

(b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in the helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel,

(c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby to form a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

15. The wire of claim 14, which is an elongate helically coiled wire formed by wrappings of a metal thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-filling body formed when the wire is released into said vessel.

16. The wire of claim 15, wherein the diameter of the coiled wire is between about 10-30 mils, and the metal thread forming the wire is platinum, gold, or tungsten.

17. A catheter system for use in occluding a vessel having a selected cross-sectional area, said system comprising:

(i) a catheter having a small-diameter inner lumen and designed to access a selected site of occlusion in said vessel,

(ii) a flexible vaso-occlusive wire characterized by;

(a) a stretched, substantially linear condition in which the wire can be pushed through said catheter;

(b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from the catheter into the vessel,

(c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from such catheter in the vessel, thereby to form a space-filling, vaso-occlusive mass which is lodged in the vessel at the site of release, and

(d) a pusher for advancing the wire in its stretched condition through the catheter to the selected site of occlusion.

18. The system of claim 17, wherein the wire is an elongate helically coiled wire formed by wrappings of platinum, gold, or tungsten thread, and the coiled wire, in its stretched condition, has a length which is at least about 15≧

20 times the diameter of the space-filling mass formed when the wire is released into the vessel.

19. The system of claim 17, wherein the pusher has a relatively long, relatively stiff metal wire proximal region, and a relatively short relatively flexible distal region formed of a low-friction polymer tubing.

20. The system of claim 19, wherein the polymer tubing is an extruded fluorocarbon polymer tubing.

21. The system of claim 19, wherein the combined diameter of the distal region of the pusher and the vaso-occlusive wire is greater than the inner lumen diameter of the catheter.

22. A method of occluding a selected site in a vessel having an inner lumen diameter of between about 2-4 mm, said method comprising

accessing the site with a catheter having a small-diameter lumen,

advancing through the catheter, a flexible vaso-occlusive wire characterized by:

(a) a stretched, substantially linear condition in which the wire can be pushed through said catheter;

(b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel,

(c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, and

releasing the wire from the catheter at the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release.

23. The method of claim 22, wherein the wire is an elongate helically coiled wire formed by wrappings of a platinum, gold, or tungsten thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-fillig body formed when the wire is released into the vessel.

24. The method of claim 22, for use in slow-release drug delivery at the vaso-occlusion site, wherein the wire contains a drug adapted for slow release into the vessel site.

25. The method of claim 22, for use in slow-release drug delivery at the vaso-occlusion site, which further includes injection a bolus of drug-containing vaso-occlusion material immediately upstream of the vaso-occlusion wire in the vessel.