Embolic elements and methods and apparatus for their delivery

• US 5,690,671 A
• Filed: 12/13/1994
• Issued: 11/25/1997
• Est. Priority Date: 12/13/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Micro Interventional Systems, Inc. (Medtronic Plc)
• Inventors: Dieck, Ronald, Tremulis, William S., McGurk, Erin
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/355,142
• Time in Patent Office: 1,078 Days
• Field of Search: 606/1, 606/191, 606/194, 606/195, 606/198, 606/32, 606/41, 606/200, 128/772, 128/784, 128/898, 128/899, 623/1, 623/12
• 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 2017/12077 Joint changing shape upon application of heat, e.g. bi-metal or reversible thermal memory
• 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

Abstract

An embolic element comprises a filament composed of a shape memory material having an unexpanded coil configuration and an expanded random matrix configuration. The embolic element may be delivered to a blood vessel treatment site in its coiled configuration over a delivery wire through a guide catheter. Usually, the coiled embolic element will be disposed over a helical section of the delivery wire prior to release. In that way, proper positioning of the embolic element may be confirmed prior to release. The embolic element is then expanded to its enlarged configuration by heating or otherwise exposing to a temperature over the transition temperature of the shape memory material.

Claims

1. An embolic element comprising a filament composed of a shape memory material having a transition temperature, wherein the filament is in an unexpanded coil configuration at a first temperature at or below the transition temperature and assumes an expanded configuration when the temperature is raised to or above the transition temperature, wherein the expanded configuration is a random matrix which defines a peripheral envelope which is larger in all dimensions than that of the unexpanded coil configuration.

2. An embolic element as in claim 1, wherein the filament has a diameter in the range from 0.01 mm to 0.1 mm and a length in the range from about 30 cm to 1000 cm, wherein the unexpanded coil has a diameter in the range from 0.1 mm to 1 mm and a length in the range from 2 mm to 600 mm, and wherein the peripheral envelope has a minimum dimension in the range from 2 mm to 100 mm.

3. An embolic element as in claim 1, wherein the shape memory material is selected from the group consisting of a nickel titanium alloy having a transition temperature in the range from 20°

C. to 70°

C. and a plastic shape memory material.

4. An embolic coil as in claim 1, further comprising a radiopaque segment attached to the wire filament.

5. An embolic coil as in claim 4, wherein the unexpanded configuration is a coil and wherein the radiopaque segment is a ring attached to at least one end of the coil, wherein the ring has a diameter which is substantially equal to that of the coil.

6. An embolic element as in claim 1, further comprising a thrombogenic component secured to the filament.

7. A system for selective occlusion of a target location within a blood vessel, said system comprising

a catheter;

an embolic element composed of a shape memory alloy having a transition temperature, an unexpanded coil configuration below the transition temperature sized to fit within or over the catheter, and an expanded configuration above the transition temperature which defines a peripheral envelope which is larger in all dimensions than that of the unexpanded configuration, wherein the expanded configuration is a random matrix which defines a peripheral envelope which is larger in all dimensions than that of the unexpanded coil configuration; and

means on the catheter for heating the embolic element to the transition temperature when the element is position at the target location.

8. A system as in claim 7, wherein the catheter comprises a tubular body having an axial lumen which receives the embolic element in its unexpanded configuration therethrough.

9. A system as in claim 7, further comprising a delivery wire having a helical distal end, wherein the delivery wire may be positioned within the axial lumen of the catheter to provide an introducing path for the embolic element.

10. A system as in claim 9, wherein the coil may be coaxially passed over the delivery wire and through the axial lumen of the catheter.

11. A system as in claim 10, wherein the coil is formed from a filament having a diameter in the range from 0.01 mm to 0.1 mm and a length in the range from about 30 cm to 1000 cm, wherein the unexpanded coil has a diameter in the range from 0.1 mm to 1 mm and a length in the range from 2 mm to 600 mm, and wherein the peripheral envelope has a minimum dimension of in the range from 2 mm to 100 mm.

12. A system as in claim 11, wherein the coil on the delivery wire has a length in the range from 1 mm to 20 mm, a diameter in the range from 2 mm to 20 mm, and consists of from 1 turn to 10 turns.

13. A method for delivering an embolic element to a target site in a blood vessel, wherein said method comprises:

positioning a delivery wire through a guide catheter so that a distal end of the delivery wire is disposed at the target site.

introducing the embolic element over the delivery wire to the target site, wherein the embolic element is composed of a shape memory material and is in an unexpanded configuration which conforms to the delivery wire as the element is being introduced; and

expanding the embolic element by exposure to a temperature above the transition temperature of the shape memory alloy.

14. A method as in claim 13, wherein the embolic element is a filament having a coiled configuration prior to expansion.

15. A method as in claim 14, wherein expanding the embolic element causes the filament to assume a random configuration having a peripheral envelope which is larger in all dimensions than that of the coiled configuration.

16. A method as in claim 13, wherein the embolic element is introduced over a helix formed at the distal end of the delivery wire, wherein the embolic element assumes a helical configuration defined by the delivery wire prior to expansion.

17. A method as in claim 13, wherein the embolic element is expanded by flushing a heated liquid medium through the guide catheter and past the embolic element at the target site.

18. A method for occluding a target location in a blood vessel, said method comprising

introducing an embolic element composed of a shape memory alloy at the target location;

heating the embolic element above a transition temperature to cause expansion of the element to an expanded configuration;

wherein thrombus forms in the expanded embolic matrix to occlude at least a portion of the target location in the blood vessel.

19. A method as in claim 18, wherein the target location is an aneurysm.

20. A method as in claim 19, wherein the embolic element is introduced in an unexpanded coil configuration over a delivery wire.

21. A method as in claim 20, wherein the delivery wire has a helical distal tip disposed in the aneurysm, wherein the coiled embolic element assumes a helical configuration as it travels over the distal helix of the delivery wire.

22. A method as in claim 21, wherein the expanded configuration of the embolic element defines a peripheral envelope which is larger in all dimensions than that of the coiled configuration.

23. A method as in claim 18, wherein the embolic element is heated by flushing a heated liquid medium past the embolic element at the target site.