Polymer embolic elements with metallic coatings for occlusion of vascular malformations

• US 6,458,127 B1
• Filed: 11/24/2000
• Issued: 10/01/2002
• Est. Priority Date: 11/22/1999
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Bruno Strul, Csaba Truckai, John H. Shadduck
• Inventors: Shadduck, John H., Truckai, Csaba, Strul, Bruno
• Primary Examiner(s): Rivell, John
• Application Number:
  US09/721,812
• Time in Patent Office: 676 Days
• Field of Search: 606/40, 606/42, 606/49, 606/50, 606/213
• US Class Current: 606/49
• 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 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 2017/12068 detachable by heat

Abstract

A system for occlusion of aneurysms comprising a class of polymer embolic elements that carry a conductive material to provide the element with a specified resistivity. The embolic element is introduced into a targeted vascular malformation from a catheter sleeve that carries an electrode arrangement at its distal terminus. After introducing any selected length of the embolic element into the vascular malformation to mechanically occlude the malformation, the physician delivers electrical current within a first selected power range to the electrode at the catheter terminus. The electrical current flows to the embolic element wherein the specified resistivity of the element controllably causes a selected thickness of coagulum to form about the surface of the embolic element to more fully occupy the volume of the malformation with occlusive material. A controller and feedback circuitry allow the embolic element to be maintained at a selected temperature to insure even build-up of the desired coagulative layer about the electrode, without risk of creating hot-spots within the aneurysm. Thereafter, the physician delivers electrical current at second higher power level to electrode arrangement to cause the embolic element to act as a fuse at the catheter terminus to divide any selected length of deployed embolic element from the remainder of the embolic element still within the catheter sleeve.

Claims

1. A system for occluding a vascular malformation, comprising:

an elongate embolic member comprising a flexible polymer core that carries a thin conductive surface layer;

an elongate catheter sleeve having a passageway that carries the embolic member;

at least one conductive electrode surface exposed about a distal portion of said passageway for contacting the surface of the embolic member; and

an electrical source coupled to said at least one conductive electrode surface.

2. The system of claim 1 further comprising a controller for controlling parameters of energy delivery from the electrical source to said at least one conductive electrode surface.

3. The system of claim 1 wherein said at least one conductive electrode surface is spaced inward of the distal termination of the catheter sleeve.

4. The system of claim 1 wherein the conductive surface layer has a thickness ranging from about 0.00001″

to 0.005″

.

5. The system of claim 1 wherein the conductive surface layer has a thickness ranging from about 0.0001″

to 0.001″

.

6. The system of claim 1 wherein the conductive surface layer has a thickness ranging from about 0.0005″

to 0.0007″

.

7. The system of claim 1 wherein the conductive surface layer is selected from the class of consisting of gold, platinum, silver, palladium, tin, tantalum, titanium, copper or combinations thereof.

8. The system of claim 1 wherein the conductive surface layer causes the elongate embolic element to have a selected resistivity ranging between about 1 ohm per 10 cm. to about 500 ohms per 10 cm. length.

9. The system of claim 1 wherein the conductive surface layer causes the elongate embolic element to have a selected resistivity ranging between about 5 ohms per 10 cm. to about 250 ohms per 10 cm.

10. The system of claim 1 wherein the conductive surface layer causes the elongate embolic element to have a selected resistivity ranging between about 30 ohms per 10 cm. to about 60 ohms per 10 cm. length.

11. The system of claim 1 wherein the flexible polymer core is of a material selected from the class consisting of nylon, PET, polyamide, aramid fiber, urethane or Kevlar®

.

12. The system of claim 1 wherein the embolic element comprises a single filament.

13. The system of claim 1 wherein the embolic element comprises multiple filaments.

14. The system of claim 2 wherein the electrical source and controller provide a first selected power level for thermally inducing coagulum to form about the embolic element.

15. The system of claim 2 wherein the electrical source and controller provide a second selected power level for thermally dividing the embolic element.

16. The system of claim 1 wherein the conductive surface layer of the embolic element comprises first and second spaced apart metallic surface portions extending about the length of the embolic element.

17. The system of claim 16 comprising first and second spaced apart electrode surfaces exposed about the distal end of the passageway of the catheter sleeve for contacting the respective first and second spaced apart metallic surface portions of the embolic element.

18. The system of claim 17 wherein the electrical source and controller provides current flow to said first and second spaced electrode surfaces having opposing polarities.

19. A method of disposition of an occlusive element within a targeted site of a patient'"'"'s vasculature, comprising:

(a) introducing an elongate polymer embolic element carrying a conductive material for providing a specified resistivity through a catheter sleeve in the patient'"'"'s vasculature so that a selected length of the polymer element is disposed within said targeted site, the selected length defined as the portion of the embolic element disposed outwardly of a distal termination of the catheter sleeve;

(b) delivering electrical current flow at a selected power level to at least one electrode carried at the distal termination of the catheter sleeve proximate to the embolic element;

(c) wherein the selected power level causes an energy density in the embolic element to separate the selected length of said element proximate to said at least one electrode; and

(d) withdrawing the catheter sleeve from the patient'"'"'s vasculature leaving said selected length at the targeted site.

20. The method of claim 19 wherein current flow in step (b) is carried to said at least one electrode functioning with a single polarity.

21. The method of claim 19 wherein current flow in step (b) is between first and second spaced apart electrodes functioning with opposing polarities.

22. A system for occluding a vascular malformation, comprising:

an elongate embolic member comprising a polymer matrix carrying a conductive material at least partially embedded therein;

an elongate catheter sleeve having a passageway that slidably carries the embolic member;

a conductive electrode surface exposed about a distal portion of said passageway; and

a remote electrical source coupled to said conductive electrode surface.

23. The system of claim 22 wherein the embolic element comprises a polymer matrix with elongate conductive filaments embedded therein.

24. The system of claim 22 wherein the embolic element comprises a polymer matrix with elongate conductive particles embedded therein.

25. A method of occluding a targeted site of a patient'"'"'s vasculature, comprising:

providing an elongate embolic element having a resistivity ranging between about 1 ohm per 10 cm. and 500 ohms per 10 cm.;

introducing the elongate embolic element through a catheter sleeve in the patient'"'"'s vasculature so that a selected length of the embolic element is disposed within the targeted site, the selected length occupying a volume of the targeted site to thereby partially mechanically occlude the targeted site; and

delivering electrical current at a selected power level to the embolic element from at least one electrode within a distal portion of the catheter sleeve;

wherein said current delivery step creates a coagulative layer about the embolic element to further mechanically occlude the targeted site.

26. The method of claim 25 wherein said current delivery step resistively heats the surface of the embolic element to denature blood compositions in contact with the embolic element thereby creating the coagulative layer.

27. The method of claim 25 wherein said current delivery step ohmically heats blood compositions proximate to the embolic element to partially create the coagulative layer.

28. The method of claim 25 further comprising the steps of providing a controller and feedback circuitry from a temperature sensor in the catheter working end and controllably maintaining the temperature of the embolic member within a selected range.

29. The method of claim 28 wherein said selected temperature range is from about 45°

C. to 100°

C.

30. The method of claim 28 wherein said selected temperature range is from about 65°

C. to 90°

C.

31. The method of claim 25 wherein the controller and feedback circuitry control the thickness of the coagulative layer.

32. The method of claim 25 wherein the step of delivering electrical current comprises delivering bi-polar flow between the first and second metallic surface portions.

33. The method of claim 32 wherein the distance between the first and second metallic surface portions is selected to thereby control the thickness of the coagulative layer.

34. The method of claim 25 wherein the embolic element is introduced into the targeted site by an axially extendable member that engages a surface of the embolic element.