Helical embolization coil

• US 6,117,157 A
• Filed: 08/25/1998
• Issued: 09/12/2000
• Est. Priority Date: 03/18/1994
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Tekulve, Kurt J.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/139,494
• Time in Patent Office: 749 Days
• Field of Search: 606/1, 606/191, 606/194, 606/195, 606/198, 606/200, 623/1, 128/899
• 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 17/12109 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A conically helically shaped embolization coil (10) for occluding a blood vessel, aneurysm, and the like. The embolization coil includes a continuous platinum-tungsten alloy wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13). The longitudinally extending coil is wound into a conically helically shaped coil (15) with a plurality of radially expanding turns (16). Distal turn (17) of the radially expanding turns has a minor diameter (18) less than a minimum diameter (34) of a vessel (32) of which the embolization is to be positioned therein. Uncompressed proximal turn (19) of the radially expanding turns has a major diameter (20) greater than a maximum diameter (33) of the vessel in which the coil to be positioned. The coil is stress relieved and, in particular, heat treated by heating the coil to a stress relief temperature of the continuous wire strand and cooled to relieve residual stresses formed during the winding of the coil and to minimize the formation of new residual stresses formed during the cool down period of the heat treatment. Thrombogenic fibers (26) are positioned in the tightly spaced turns of the coil to attract thrombus and build up a mass that occludes the vessel lumen. The embolization coil (10) can also include first and second conically helically shaped coils (15, 45) that expand radially in generally opposite directions. The multiple helically shaped coils (15, 45) of the embolization coil accurately and centrally position the embolization coil in the vessel. Each coil acts as an anchor for the other to cause the turns of the coil to make longitudinal contact with each other regardless of the direction of blood flow thereagainst. The longitudinally extending coil (12) of the embolization coil (10) can also be formed to include distal and proximal end turns extending longitudinally from the conically helically shaped coil (15) to better affix and centrally position the embolization coil at the occlusion site.

Claims

1. An embolization coil (10) comprising:

a wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13), said longitudinally extending coil wound into a first conically helically shaped coil (15) having a first plurality of radially expanding turns (16) expanding in a first direction (44) and into a second conically helically shaped coil (45) having a second plurality of radially expanding turns (46) expanding in a second direction (47) generally opposite to said first direction (44), the turns of at least one of said first and said second plurality of radially expanding turns longitudinally overlapping each other, whereby the turns of said at least one of said first and said second plurality of radially expanding turns longitudinally contact each other in response to blood flowing therethrough to occlude a vessel in which the embolization coil is positioned.

2. The embolization coil of claim 1, wherein said first and said second conically shaped coil is heat treated to relieve stresses that are formed when winding said longitudinally extending coil and said first and said second conically helically shaped coil.

3. The embolization coil of claim 1, wherein said wire strand is comprised of a metallic alloy and wherein conically helically shaped coil is formed by the steps of:

winding said longitudinally extending coil around a longitudinally tapered mandril (23) that increases in diameter in opposite directions with a plurality of turns (16,

     46), heating said first and said second conically helically shaped coil when wound around said longitudinally tapered mandril at a stress relief temperature of said metallic alloy for a first time period, and cooling said conically helically shaped coil when wound around said longitudinally tapered mandril from said stress relief temperature for a second time period greater than said first time period.

4. The embolization coil of claim 3, wherein the steps of forming said first and said second conically helically shaped coil further include selecting said longitudinally tapered mandril of a material (25) that remains substantially free of surface oxidation during heating and cooling of said first and said second conically helically shaped coil.

5. The embolization coil of claim 3, wherein said metallic alloy comprises at least one from a group consisting of platinum, stainless steel, iridium, palladium, tungsten, and gold.

6. The embolization coil of claim 1, wherein said first and said second conically helically shaped coil is heated at a stress relief temperature of said continuous wire strand for a first time period and then gradually cooled down from said stress relief temperature for a second time period greater than said first time period.

7. The embolization coil of claim 1, wherein said wire strand comprises a metallic material (22) that is substantially free of surface oxidation.

8. The embolization coil of claim 1, further comprising thrombogenic fibers (26) positioned in said plurality of tightly spaced turns of said longitudinally extending coil.

9. An embolization coil (10) comprising:

a wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13), said longitudinally extending coil wound into a conically helically shaped coil (15) having a plurality of radially expanding turns (16) expanding in a first direction (44), said plurality of radially expanding turns longitudinally overlapping each other and including a distal turn (17) having a minor diameter (18) said longitudinally extending coil (12) being also wound into at least one end turn (48) extending from said distal turn of said plurality of radially expanding turns in a second direction (47) generally opposite to said first direction and having an end diameter (49) larger than said minor diameter, whereby said radially expanding turns longitudinally contact each other in response to blood flowing therethrough to occlude a site in which the embolization coil is positioned.

10. The embolization coil of claim 9, wherein said conically helically shaped coil is heat treated to relieve stresses that are formed when winding said longitudinally extending coil and said conically helically shaped coil.

11. The embolization coil of claim 10, wherein said conically helically shaped coil is formed by the steps of:

winding said longitudinally extending coil around a longitudinally tapered mandril (23) and heating said conically helically shaped coil at a stress relief temperature of said metallic alloy for a first time period and then cooling said conically helically shaped coil down from said stress relief temperature for a second time period greater than said first time period.

12. The embolization coil of claim 9, wherein said conically helically shaped coil is formed by the steps of:

winding said longitudinally extending coil around a longitudinally tapered mandril (23) with a plurality of turns (16) and heat treating said conically helically shaped coil when wound around said longitudinally tapered mandril to relieve residual stresses formed therein.

13. The embolization coil of claim 12, wherein the wire strand comprises a metallic alloy, the metallic alloy comprises at least one from a group consisting of platinum, stainless steel, iridium, palladium, tungsten, and gold.

14. The embolization coil of claim 9, wherein the wire strand comprises a metallic alloy, the metallic alloy includes at least one from a group consisting of platinum, stainless steel, iridium, palladium, tungsten, and gold.

15. An embolization coil (10) comprising:

a wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13), said longitudinally extending coil wound into a conically helically shaped coil (15) having a plurality of radially expanding turns (16), said plurality of radially expanding turns longitudinally overlapping each other and including a distal turn (17) having a minor diameter (18) and a proximal turn (19) having a major diameter (20), said longitudinally extending coil being also wound into at least one proximal end turn (50) extending from said first proximal turn and having an end diameter (51) no greater than said major diameter, whereby said radially expanding turns longitudinally contact each other in response to blood flowing against to occlude a site in which the embolization coil is positioned.

16. The embolization coil of claim 15, wherein the end diameter of said at least one proximal end turn is less than said major diameter of said proximal turn.

17. The embolization coil of claim 15, wherein said conically helically shaped coil is heat treated to relieve stresses that are formed when winding said longitudinally extending coil and said conically helically shaped coil.

18. The embolization coil of claim 15, wherein said conically helically shaped coil is formed by the steps of:

winding said longitudinally extending coil around a longitudinally tapered mandril (23) with a plurality of turns (24) and heat treating said conically helically shaped coil when wound around said longitudinally tapered mandril to relieve residual stresses formed therein.

19. The embolization coil of claim 15, wherein the wire strand comprises a metallic alloy, the metallic alloy includes at least one from a group consisting of platinum, stainless steel, iridium, palladium, tungsten, and gold.

20. The embolization coil of claim 15, wherein said conically helically shaped coil is formed by the steps of:

winding said longitudinally extending coil around a longitudinally tapered mandril (23) and heating said conically helically shaped coil at a stress relief temperature of said metallic alloy for a first time period and then cooling said conically helically shaped coil down from said stress relief temperature for a second time period greater than said first time period.